Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genitope Corporation
• Treatments: Antibodies; Cyclophosphamide; Immunoglobulin Idiotypes; Immunoglobulins; Immunoglobulins, Intravenous; Keyhole-limpet hemocyanin; Prednisone; Sargramostim; Vaccines; Vincristine

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

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

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

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