Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00134082

Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells

PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Biological: filgrastim Biological: rituximab Drug: cyclophosphamide	Phase I Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Cyclophosphamide Granulocyte-macrophage colony-stimulating factor Filgrastim Sargramostim Rituximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma

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

Primary Outcome Measures:

Safety and tolerability [ Designated as safety issue: Yes ]
Immunologic response [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relapse-free survival at 3 years [ Designated as safety issue: No ]
Overall survival at 3 years [ Designated as safety issue: No ]
Patterns of cellular immune reconstitution [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	July 2005
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients with relapsed Hodgkin lymphoma.
Determine the immunologic response to this vaccine in these patients.

Secondary

Determine the 3-year relapse-free and overall survival of patients treated with this regimen.
Determine the patterns of cellular immune reconstitution in patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks 4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.

After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 25 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 classical Hodgkin's lymphoma
Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy
- No primary induction failure, defined as disease progression during or within 2 months after completion of first-line therapy

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 75,000/mm^3

Hepatic

Bilirubin ≤ 2.0 mg/dL* NOTE: *Unless due to lymphoma or Gilbert's syndrome

Renal

Creatinine ≤ 2.0 mg/dL

Cardiovascular

Ejection fraction ≥ 45% by echocardiogram or MUGA

Pulmonary

DLCO ≥ 50% of predicted (corrected for alveolar volume)

Immunologic

No known HIV positivity
No active infection requiring oral or IV antibiotics
No autoimmune or other disease requiring long-term systemic steroids or other long-term immunosuppressants

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to tolerate high-dose therapy
No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior bone marrow transplantation

Endocrine therapy

Not specified

Radiotherapy

Concurrent radiotherapy for disease progression after high-dose cyclophosphamide allowed at the discretion of the principal investigator

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134082

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Yvette L. Kasamon, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Yvette Leslie Kasamon )
Study ID Numbers:	CDR0000441037, JHOC-J0528
Study First Received:	August 22, 2005
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00134082 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Immunologic Factors
Hodgkin Lymphoma, Adult
Rituximab
Hodgkin's Disease
Cyclophosphamide
Immunosuppressive Agents
Recurrence

Lymphatic Diseases
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antirheumatic Agents
Alkylating Agents
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions

Lymphatic Diseases
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoproliferative Disorders
Alkylating Agents
Hodgkin Disease
Lymphoma

ClinicalTrials.gov processed this record on May 07, 2009