Cellular Adoptive Immunotherapy in Treating Patients With Relapsed or Refractory Follicular Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Cellular adoptive immunotherapy uses a person's white blood cells that are treated in the laboratory to stimulate the immune system in different ways and stop cancer cells from growing. Rituximab and fludarabine may also prevent the body from making an immune response against the laboratory-treated white blood cells that are put back into the body. Interleukin-2 may help the laboratory-treated white blood cells stay in the body longer. Giving cellular adoptive immunotherapy together with rituximab, fludarabine, and interleukin-2 may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with relapsed or refractory follicular non-Hodgkin's lymphoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Fludarabine; Fludarabine phosphate; Rituximab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed follicular non-Hodgkin's lymphoma (NHL)

• High-risk disease, as defined by any of the following:

• Relapsed within 6 months after the last treatment

• Failed to achieve a complete response during the last treatment

• Relapsed after prior autologous hematopoietic stem cell transplantation (HSCT)

• No current transformation of lymphoma (e.g., elements of intermediate- or high-grade lymphoma by biopsy)

• No active CNS disease by lumbar puncture or radiology scan NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

• 16 to 70

Performance status

• Karnofsky 50-100%

Life expectancy

• More than 16 weeks

Hematopoietic

• Absolute neutrophil count > 500/mm^3

Hepatic

• Bilirubin ≤ 1.5 times upper limit of normal (ULN)* (unless due to Gilbert's disease)

• ALT ≤ 2.5 times ULN* NOTE: *Unless due to NHL

Renal

• Creatinine ≤ 1.5 times ULN* OR

• Creatinine clearance ≥ 80 mL/min* NOTE: *Unless due to NHL

Immunologic

• HIV negative

• Epstein-Barr virus positive

• No history of allergy or intolerance to ganciclovir

Other

• Negative pregnancy test

• No history of another malignancy except basal cell skin cancer or carcinoma in situ

• No other uncontrolled or severe illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior allogeneic HSCT

• No other immunotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the Principal Investigator (PI)

Chemotherapy

• No other chemotherapy during and for approximately 65 days after the last T-cell infusion, unless approved by the PI

• Patients may receive chemotherapy after leukapheresis while waiting for CD19-specific T cells to be manufactured

Endocrine therapy

• No systemic corticosteroids during and for approximately 65 days after the last T-cell infusion, unless approved by the PI

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• No concurrent participation in another investigational study

• No immunosuppression agents or other investigational agents during and for approximately 65 days after the last T-cell infusion, unless approved by the PI