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Vaccine Therapy and Sargramostim in Treating Adults With Metastatic Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00091000
  Purpose

RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with sargramostim works in treating patients with metastatic cancer .


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: falimarev
Drug: inalimarev
Drug: sargramostim
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Colorectal Cancer Ovarian Cancer
Drug Information available for: Sargramostim Granulocyte-macrophage colony-stimulating factor PANVAC-V
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Objective response by RECIST every 2 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare immunologic response by ELISPOT at baseline and day 71 [ Designated as safety issue: No ]
  • Safety by CTCAE v 3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: July 2004
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety and tolerability of vaccination comprising recombinant vaccinia-CEA-MUC-1-TRICOM vaccine, recombinant fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim (GM-CSF) in patients with carcinoembryonic antigen- or MUC-1 antigen-expressing metastatic carcinoma (colorectal* or non-colorectal cancer).
  • Determine the clinical response in patients with ovarian or breast carcinoma treated with this vaccine.

Secondary

  • Determine objective antitumor response in patients with colorectal* or non-colorectal* cancer treated with this regimen.
  • Determine the safety and tolerability of this regimen in patients with ovarian or breast carcinoma.
  • Determine immune response in patients treated with this regimen. NOTE: *No longer accruing patients other than those with breast cancer as of 11/1/2007.

OUTLINE: This is a non-randomized, open-label, pilot study. Patients are stratified according to disease type (colorectal carcinoma vs noncolorectal* carcinoma vs breast carcinoma vs ovarian carcinoma).

NOTE: *No longer accruing patients other than those with breast cancer as of 11/1/2007.

  • Core phase: Patients receive recombinant vaccinia-CEA-MUC-1-TRICOM vaccine subcutaneously (SC) on day 1 and recombinant fowlpox-CEA-MUC-1-TRICOM vaccine SC on or about days 15, 29, and 43. Patients also receive sargramostim (GM-CSF) SC on days 1-4 and on or about days 15-18, 29-32, and 43-46.
  • Extension phase: Patients who do not have progressive disease after the core phase receive recombinant fowlpox-CEA-MUC-1-TRICOM vaccine SC on day 1 and 29 and GM-CSF SC on days 1-4. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Maintenance Phase: Patients who do not have progressive disease after the extension phase receive maintenance recombinant fowlpox-CEA-MUC-1-TRICOM vaccine SC every 3 months and GM-CSF SC on days 1-4. Patients who have radiographic evidence of progressive disease but are clinically stable may continue treatment monthly as in the extension phase.

Patients are followed every 4 weeks for 3 months and then annually for up to 15 years.

PROJECTED ACCRUAL: Approximately 51 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed colorectal*, noncolorectal*, ovarian, or breast carcinoma

    • Measurable or evaluable metastatic disease (for patients with colorectal* or noncolorectal* disease)
    • Metastatic disease documented by biopsy but not evaluable by radiographic imaging (e.g., small volume peritoneal disease) (for patients with colorectal* or noncolorectal* disease)
    • Surgically resected metastatic disease at high-risk of relapse (for patients with colorectal* or noncolorectal* disease)
    • Carcinoembryonic antigen (CEA)- or MUC-1 antigen-positive (≥ 20% of cells) by immunohistochemistry OR elevated CEA (> 5 μg/L) at any point during the course of disease (for patients with colorectal* or noncolorectal* disease)
    • Evaluable metastatic disease (for patients with ovarian and breast carcinoma)
  • HLA-A2 positive (for patients with colorectal carcinoma*)

    • At least 10 patients with noncolorectal* carcinoma must be HLA-A2-positive
    • Patients with breast and ovarian carcinoma are not required to be HLA-A2 positive
  • Completed ≥ 1 fluorouracil-containing chemotherapy regimen (e.g., fluorouracil and leucovorin calcium with or without either irinotecan or oxaliplatin) for colorectal carcinoma*

    • Patients with noncolorectal*, breast, or ovarian carcinoma must have failed OR be ineligible for therapy of proven efficacy
  • No evidence of clinically active brain metastasis
  • Hormone receptor status

    • Not specified NOTE: *No longer accruing patients other than those with breast cancer as of 11/1/2007

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Menopausal status

  • Not specified

Sex

  • Male or female

Performance status

  • ECOG 0-1

Life expectancy

  • 6 months or longer

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • Bilirubin normal (≤ 3.0 mg/dL for patients with Gilbert's disease)
  • AST ≤ 2 times upper limit of normal
  • Hepatitis B and C negative

Renal

  • Creatinine normal OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No clinically significant cardiomyopathy
  • No cardiac complications including a cerebrovascular accident within the past year
  • No symptomatic congestive heart failure unless stable on treatment
  • No symptomatic arrhythmia unless controlled by medication
  • No unstable atherosclerotic heart disease requiring active intervention
  • No history of myocardial infarction or embolic stroke within the past 6 months
  • No history of cardiomyopathy or symptomatic congestive heat failure (unless stable on treatment)
  • No history of symptomatic arrhythmia (unless controlled by medication)
  • No unstable atherosclerotic heat disease (e.g., unstable angina) requiring active intervention

Immunologic

  • HIV negative
  • No active autoimmune disease requiring treatment OR history of autoimmune disease that may be stimulated by vaccine therapy
  • No allergy or untoward reaction to prior vaccinia virus vaccine
  • No altered immune function, including any of the following conditions:

    • Immunodeficiency
    • Eczema or other eczematoid skin disorders
    • Acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • No serious hypersensitivity reaction to egg products
  • No inflammatory eye condition that may require medication during study treatment
  • No active infection with fever > 100°F

Gastrointestinal

  • No inflammatory bowel disease
  • No Crohn's disease
  • No ulcerative colitis
  • No active diverticulitis

Other

  • Endocrine disease, including thyroid disease, adrenal disease, and vitiligo, that is controlled by replacement therapy allowed
  • Clinically stable to complete the full 3 month course of vaccination
  • No close household contact (sharing housing or having close physical contact) with the following individuals for 3 weeks after each vaccination:

    • Individuals with active or history of eczema or other eczematoid skin disorders
    • Individuals with other unresolved acute, chronic, or exfoliative skin disorders (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
    • Pregnant or nursing women
    • Children under 3 years of age
    • Immunodeficient or immunosuppressed individuals (by disease or therapy), including HIV-positive individuals
  • No other serious medical condition that would preclude study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after completion of study treatment (unless prior hysterectomy or bilateral oopherectomy)
  • No history of encephalitis, multiple sclerosis, or seizures (from seizure disorder or brain metastasis) within the past year

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior immunotherapy with related vaccinia or fowlpox vaccines or antigen-specific peptides allowed
  • No other concurrent anticancer immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 6 weeks since prior nitrosoureas or mitomycin
  • No concurrent chemotherapy unless receiving trastuzumab (Herceptin) for breast cancer treatment

Endocrine therapy

  • No concurrent systemic steroids except physiologic doses for systemic steroid replacement OR local (topical, nasal, or inhaled) steroid use

    • Limited doses of systemic steroids allowed for prevention of allergic or anaphylactic reaction to IV contrast agents for patients with known allergy to contrast media
  • No steroid eye drops for 2 weeks before until 4 weeks after initial vaccinia vaccination
  • No concurrent anticancer hormonal therapy

    • Patients with prostate cancer who have not undergone orchiectomy must continue gonadotropin-releasing hormone agonist therapy

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • No concurrent major surgery

Other

  • Recovered from all prior therapy
  • More than 72 hours since prior antibiotics
  • No known prior vaccina vaccination (small pox vaccine)
  • No other concurrent antineoplastic therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00091000

Locations
United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20892-9255
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Principal Investigator: James Gulley, MD, PhD National Cancer Institute (NCI)
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Web site for additional information  This link exits the ClinicalTrials.gov site

Publications:
Arlen PM, Gulley JL, Parker C, et al.: A pilot study of concurrent docetaxel plus PSA pox-vaccine versus vaccine alone in metastatic androgen independent prostate cancer (AIPC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1701, 2003.
Fairchok MP, Trementozzi DP, Carter PS, Regnery HL, Carter ER. Effect of prednisone on response to influenza virus vaccine in asthmatic children. Arch Pediatr Adolesc Med. 1998 Dec;152(12):1191-5.

Study ID Numbers: CDR0000381300, NCI-04-C-0246, NCI-6536
Study First Received: September 7, 2004
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00091000  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage IV colon cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
unspecified adult solid tumor, protocol specific
recurrent breast cancer
stage IV breast cancer
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
stage IV ovarian epithelial cancer
stage IV ovarian germ cell tumor
male breast cancer

Study placed in the following topic categories:
Gonadal Disorders
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Rectal Diseases
Genital Diseases, Female
Neoplasm Metastasis
Rectal cancer
Breast Diseases
Endocrine Gland Neoplasms
Ovarian cancer
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Vaccinia
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Intestinal Diseases
Intestinal Neoplasms
Recurrence
Rectal neoplasm
Carcinoma
Digestive System Diseases
Breast Neoplasms, Male
Gastrointestinal Neoplasms
Endocrinopathy

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009