Vaccine Therapy Plus Sargramostim Following Chemotherapy in Treating Patients With Previously Untreated Aggressive Non-Hodgkin's Lymphoma
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase II trial of vaccine therapy plus sargramostim following chemotherapy in treating patients who have previously untreated aggressive non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: keyhole limpet hemocyanin Biological: sargramostim Biological: tumor cell-based vaccine therapy Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: mitoxantrone hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Trial to Evaluate the Rate of Immune Response Using Idiotype Immunotherapies Produced by Molecular Biological Means for Treatment of Aggressive B Cell Lymphoma |
| Study Start Date: | June 1999 |
| Study Completion Date: | November 2003 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the ability of recombinant idiotype immunotherapy to stimulate a specific immune response against the B cell idiotype of the malignant clone that constitutes the tumor in patients with previously untreated aggressive non-Hodgkin's lymphoma. II. Determine the safety and toxicity of this treatment regimen using Genitope Corporation's molecular rescue technology in this patient population.
OUTLINE: Patients receive induction chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or cyclophosphamide, mitoxantrone, vincristine, and prednisone (CNOP). Treatment repeats every 3 weeks until the maximal clinical response is achieved followed by 2 additional courses of consolidation therapy for up to a maximum of 6 courses. At 2-6 months following completion of chemotherapy, patients achieving adequate disease response receive vaccination consisting of recombinant tumor derived immunoglobulin idiotype with keyhole limpet hemocyanin conjugate subcutaneously (SQ) followed by sargramostim (GM-CSF) SQ, each at 2 separate sites on day 1. Patients receive GM-CSF alone on days 2-4. Vaccination repeats every 4 weeks for 4 doses, followed 3 months later by the fifth and final dose. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter until disease progression.
PROJECTED ACCRUAL: Not specified
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma Diffuse mixed cell Diffuse large cell Immunoblastic Follicular large cell with more than 50% large cells Mantle cell Non-age adjusted International Prognostic Index 2-4 Tumor sample safely accessible by biopsy, needle aspiration, or phlebotomy Must have adequate circulating lymphoma cells No CNS metastasis
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: WBC greater than 2,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Other: No other illness or condition, including innate or pharmacologic immunosuppression, that would preclude study No other malignancy within the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after the study
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for lymphoma Chemotherapy: No prior cytotoxic chemotherapy for lymphoma Endocrine therapy: No prior steroids for lymphoma At least 2 months since prior nonphysiologic doses of prednisone of greater than 20 mg or equivalent No concurrent maintenance steroids or greater than 5mg of daily prednisone or equivalent Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified
Contacts and Locations| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305-5408 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-3330 | |
| Study Chair: | Julie M. Vose, MD | University of Nebraska |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004197 History of Changes |
| Other Study ID Numbers: | 197-99, P30CA036727, UNMC-197-99, GENITOPE-9902, SUMC-9902 |
| Study First Received: | January 21, 2000 |
| Last Updated: | June 23, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Nebraska:
|
stage I grade 3 follicular lymphoma stage I adult diffuse mixed cell lymphoma stage I adult diffuse large cell lymphoma stage I adult immunoblastic large cell lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma stage III adult immunoblastic large cell lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage I mantle cell lymphoma |
contiguous stage II grade 3 follicular lymphoma contiguous stage II mantle cell lymphoma contiguous stage II adult diffuse mixed cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Doxorubicin Mitoxantrone Prednisone Vincristine Keyhole-limpet hemocyanin |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013