Immunotherapy Using Cyclosporine, Interferon Gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

• Status: Completed
• 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. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell transplantation may help the transplanted cells make an immune response and kill any remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by autologous stem cell transplantation is more effective with or without immunotherapy.

PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem cell transplantation only in treating patients with refractory or relapsed Hodgkin's lymphoma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Carmustine; Cyclosporine; Cyclosporins; Cytarabine; Etoposide; Etoposide phosphate; Interferon-gamma; Interferons; Interleukin-2; Lenograstim; Melphalan

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of Hodgkin's lymphoma

• Histologically confirmed at original diagnosis AND at relapse or disease progression

• Relapsed or refractory to conventional therapy

• No recurrence without B symptoms or bulky disease at least 1 year after completion of minimal systemic therapy defined by either of the following:

• Stage IA/IIA with nodal disease previously treated with radiotherapy only

• Stage IA/IIA with nodal disease previously treated with less than 3 courses of standard dose chemotherapy

• Concurrently enrolled on the COG-AHOD00P1 salvage chemotherapy study OR received other appropriate salvage therapy (e.g., ifosfamide and vinorelbine)

PATIENT CHARACTERISTICS:

Age

• Under 30

Performance status

• ECOG 0-2 (for adults)

• Lansky 50-100% (for children)

Life expectancy

• At least 2 months

Hematopoietic

• Absolute neutrophil count at least 500/mm^3

Hepatic

• Bilirubin no greater than 1.5 times normal

• SGPT less than 2.5 times normal

Renal

• Creatinine no greater than 1.5 times normal OR

• Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2

Cardiovascular

• Shortening fraction at least 27% by echocardiogram OR

• Ejection fraction at least 50% by MUGA

Pulmonary

• No evidence of dyspnea at rest

• No exercise intolerance

• DLCO at least 50% (patients 8 years of age and over)

Other

• Not pregnant or nursing

• Negative pregnancy test

• No concurrent serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Recovered from prior immunotherapy

• At least 1 week since prior antineoplastic biologic agents

• More than 1 week since prior growth factors

• No prior stem cell transplantation

• No other concurrent immunomodulating agents

Chemotherapy

• See Disease Characteristics

• More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered

• No other concurrent anticancer chemotherapy

Endocrine therapy

• No concurrent steroids, including dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics

• Recovered from prior radiotherapy

Surgery

• Not specified

Other

• No concurrent participation in another COG therapeutic study