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Phase III Randomized Study of Cyclophosphamide, Prednisone, and Vincristine Followed By Immunotherapy With Keyhole Limpet Hemocyanin With or Without Recombinant Autologous Tumor-Derived Immunoglobulin Idiotype and Adjuvant Sargramostim (GM-CSF) in Patients With Stage III or IV Follicular B-Cell Non-Hodgkin's Lymphoma
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Trial Contact Information Registry Information
Alternate Title
Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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18 and over
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GENITOPE-G2000-03 CUMC-0101-142, UCLA-0010061, NCT00017290
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Objectives - Compare the time to tumor progression in patients with stage III or IV follicular B-cell non-Hodgkin's lymphoma treated with cyclophosphamide, prednisone, and vincristine followed by immunotherapy with keyhole limpet hemocyanin with or without autologous tumor-derived immunoglobulin idiotype and adjuvant sargramostim (GM-CSF).
- Compare the efficacy of these immunotherapy regimens in terms of converting patients with partial response or unconfirmed complete response to clinical complete response.
- Compare the safety and toxic effects of these immunotherapy regimens in this patient population.
- Compare the time to treatment failure and survival of patients treated with these regimens.
- Correlate the induction of idiotype-specific immune response with clinical benefits of achieving molecular remission in these patients.
- Compare the quality of life of patients treated with these regimens.
Entry Criteria Disease Characteristics:
- Histologically confirmed stage III or IV follicular B-cell non-Hodgkin's lymphoma
- At least 1 bidimensionally measurable lesion by radiography, in addition
to
lesion removed for biopsy
- No clinical evidence of CNS involvement
Prior/Concurrent Therapy:
Biologic therapy: - No prior antibody therapy for lymphoma
Chemotherapy: - No prior cytotoxic therapy for lymphoma
Endocrine therapy: - No prior corticosteroids for lymphoma
- At least 12 months since prior corticosteroids or
immunosuppressants for other conditions
- Prior transient corticosteroids (prior to CT imaging) or
optical solutions allowed
Radiotherapy: - Prior radiotherapy for lymphoma (no more than 2 sites of
limited disease) allowed
Surgery: - See Disease Characteristics
Other: - No concurrent participation in other therapeutic clinical
trial
Patient Characteristics:
Age: Performance status: Life expectancy: Hematopoietic: - WBC greater than 1,500/mm3
- Platelet count greater than 100,000/mm3
Hepatic: - Bilirubin less than 1.5 times upper limit of normal
(ULN)
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal: - Creatinine less than 1.5 times ULN
Other: - No other malignancy within the past 5 years except adequately
treated basal or squamous cell skin cancer or carcinoma in situ of the
cervix
- No history of autoimmune disease
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Expected Enrollment A total of 360 patients (240 in arm I and 120 in arm II) will be accrued from
the 480 patients biopsied for this study within 15-18 months. Outline This is a randomized, double-blind, placebo-controlled, multicenter
study. Patients receive cyclophosphamide IV over 30-40 minutes and vincristine
IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment
repeats every 21 days for 8 courses. At 6 months after completion of chemotherapy, patients maintaining
partial response (PR), complete response (CR), or unconfirmed complete
response (CRU) receive immunotherapy. Patients are stratified according to
participating center and baseline disease status (PR vs CR/CRU). Patients are
randomized to one of two treatment arms. - Arm I: Patients receive autologous tumor-derived immunoglobulin idiotype
conjugated to keyhole limpet hemocyanin (KLH) subcutaneously (SC) on day 1 and
adjuvant sargramostim (GM-CSF) SC on days 1-4 of weeks 0, 4, 8, 12, 16, 20,
and 24.
- Arm II: Patients receive KLH alone SC on day 1 and GM-CSF SC on days 1-4
of weeks 0, 4, 8, 12, 16, 20, and 24.
Quality of life is assessed prior to first immunization, at 2-8 weeks
after completion of immunizations, and then every 6 months for 30
months. Patients are followed every 3 months for 1 year and then every 6 months
thereafter. Patients also enroll in a long-term follow-up study for an
additional 5 years.
Trial Contact Information
Trial Lead Organizations Genitope Corporation | | | David Hinds, Protocol chair | | | |
Registry Information | | Official Title | | A Phase III Trial To Evaluate The Safety And Efficacy Of Specific Immunotherapy, Recombinant Idiotype Conjugated To KLH With GM-CSF, Compared To Non-Specific Immunotherapy, KLH With GM-CSF, In Patients With Follicular Non-Hodgkin's Lymphoma | | Trial Start Date | | 2000-11-01 | | Registered in ClinicalTrials.gov | | NCT00017290 | | Date Submitted to PDQ | | 2001-04-16 | | Information Last Verified | | 2002-08-29 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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