Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination chemotherapy may be a more effective treatment for mantle cell lymphoma.

PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2 after combination chemotherapy works in treating patients with relapsed or de novo stage II, stage III, or stage IV mantle cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: Lymphoma Research Foundation; National Cancer Institute (NCI); Novartis
• Treatments: Aldesleukin; BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Doxorubicin; Interleukin-2; Liposomal doxorubicin; Methotrexate; Prednisone; Vaccines; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed mantle cell lymphoma

• Stage II, III, or IV disease

• Relapsed or de novo disease

• No symptomatic brain metastasis

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

• Not specified

Hematopoietic

• White blood count (WBC) > 3,000/mm^3

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Hematocrit > 25%

• Hemoglobin > 8 g/dL

Hepatic

• Bilirubin < 2.0 mg/dL

Renal

• Creatinine < 2.0 mg/dL OR

• Creatinine clearance > 60 mL/min

Immunologic

• No serious ongoing infection

• No known HIV infection

• No other pre-existing immunodeficiency condition

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent immunotherapy

Chemotherapy

• More than 4 weeks since prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• More than 4 weeks since prior steroids

• No concurrent corticosteroids except as replacement doses in patients who are hypoadrenal

Radiotherapy

• More than 2 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent immunosuppressive therapy