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Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
This study is ongoing, but not recruiting participants.
First Received: January 28, 2000   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: The Cleveland Clinic
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004244
  Purpose

RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.

Interferon alfa may interfere with the growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma.


Condition Intervention Phase
Kidney Cancer
Melanoma (Skin)
Biological: recombinant interferon alfa
Biological: recombinant interleukin-12
Phase I

MedlinePlus related topics: Cancer Kidney Cancer Melanoma
Drug Information available for: Interferon alfa-2a Interleukin-12 Interferon alfa-n1 Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma

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

Study Start Date: March 2000
Detailed Description:

OBJECTIVES:

  • Determine the toxicity of interleukin-12 and interferon alfa in patients with metastatic renal cell carcinoma or malignant melanoma.
  • Determine the maximum tolerated dose of these drugs when concurrently administered in this patient population.
  • Obtain preliminary data on the antitumor efficacy of this combination in these patients.

OUTLINE: This is a dose-escalation study, followed by a randomized study.

Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities.

Once the MTD is established, additional patients are accrued and randomized to 1 of the following treatment arms:

  • Arm I: Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
  • Arm II: Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
  • Arm III: Patients receive treatment with interleukin-12 in combination with interferon alfa at the MTD as described above.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for the dose escalation portion of this study. An additional 18 patients (5 in arm I, 5 in arm II, and 8 in arm III) will be accrued to the randomized portion of this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed renal cell carcinoma or malignant melanoma
  • Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor
  • Bidimensionally measurable of evaluable disease
  • No significant effusions and/or ascites
  • No more than 3 prior regimens for metastatic disease
  • No known CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.5 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • ALT/AST no greater than 3 times upper limit of normal

Renal:

  • Creatinine no greater than 1.8 mg/dL
  • Calcium no greater than 11.5 mg/dL

Cardiovascular:

  • No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment
  • No congestive heart failure
  • No angina pectoris
  • No New York Heart Association class III or IV heart disease

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active peptic ulcer
  • No autoimmune disease
  • No inflammatory bowel disease
  • No local or systemic infections requiring IV antibiotics within the past 28 days
  • No known seizure disorder
  • No other prior malignancy except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any curatively treated malignancy in complete remission for at least 3 years
  • HIV, hepatitis B surface antigen, and hepatitis C negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • Recovered from prior biologic therapy

Chemotherapy:

  • See Disease Characteristics
  • Recovered from prior chemotherapy

Endocrine therapy:

  • See Disease Characteristics
  • At least 28 days since prior hormonal therapy and recovered
  • No concurrent corticosteroids except for replacement steroids

Radiotherapy:

  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • At least 28 days since prior radiotherapy for control of pain from skeletal lesions

Surgery:

  • See Disease Characteristics
  • At least 28 days since prior major surgery requiring general anesthesia
  • No organ allografts

Other:

  • No concurrent aspirin
  • No concurrent barbiturates
  • No other concurrent investigational agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004244

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Study Chair: Ronald M. Bukowski, MD The Cleveland Clinic
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067489, CCF-IRB-3063, NCI-T99-0028
Study First Received: January 28, 2000
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00004244     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV renal cell cancer
recurrent renal cell cancer
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Urinary Tract Neoplasm
Interferon Type I, Recombinant
Interleukin-12
Immunologic Factors
Urogenital Neoplasms
Urologic Neoplasms
Melanoma
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevus, Pigmented
Neuroepithelioma
Kidney Diseases
Interferon-alpha
Kidney Cancer
Interferons
Adjuvants, Immunologic
Angiogenesis Inhibitors
Antiviral Agents
Recurrence
Neuroendocrine Tumors
Carcinoma
Neuroectodermal Tumors
Carcinoma, Renal Cell
Nevus
Adenocarcinoma
Interferon Alfa-2a
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Anti-Infective Agents
Interferon Type I, Recombinant
Interleukin-12
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Urogenital Neoplasms
Urologic Neoplasms
Melanoma
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Growth Inhibitors
Angiogenesis Modulating Agents
Kidney Diseases
Interferon-alpha
Neoplasms by Histologic Type
Growth Substances
Interferons
Adjuvants, Immunologic
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on May 07, 2009