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ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER


Phase 2
18 Years
N/A
Not Enrolling
Both
Kidney Cancer, Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

ALPHA INTERFERON, TUMOR INFILTRATING LYMPHOCYTES, AND INTERLEUKIN-2 IN THE TREATMENT OF CANCER


OBJECTIVES: I. Determine the response rate and failure-free survival in patients with
metastatic cancer (preferably melanoma or renal cell) treated with autologous tumor
infiltrating lymphocytes (TIL), interferon alfa (IFN-A), and interleukin-2 (IL-2). II.
Describe the toxic effects and costs associated with this therapy to assess risk benefit and
cost benefit. III. Assess the relative value of administering low- or high-dose TIL, as well
as the value of administering IFN-A before TIL, IL-2 with TIL, or cimetidine with TIL.

OUTLINE: This is a multicenter study. Patients are stratified according to center, tumor
infiltrating lymphocyte (TIL) dose (low vs high), and medical condition suitable for
interferon alfa (IFN-A)/interleukin-2 (IL-2) (yes vs no). Patients are assigned to one of
two treatment regimens based on entry criteria. Regimen A (preferred): Patients meeting the
preferred entry criteria receive IFN-A subcutaneously on days 1-4, TIL expanded in vitro
with IL-2 IV on day 5, and IL-2 IV continuously over 72 hours following TIL infusion.
Regimen B: All other patients receive TIL infusion once followed by oral cimetidine every 6
hours for 4 weeks. Treatment repeats in both regimens every 3-6 weeks in the absence of
disease progression and according to TIL availability. Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 20-30 patients with melanoma and 20-30 patients with renal
cell carcinoma will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologic evidence of any type of cancer with metastases
Melanoma or renal cell cancer preferred No active brain metastasis Tumor infiltrating
lymphocytes must be available Measurable or evaluable disease preferred

PATIENT CHARACTERISTICS: Age: 18 and over (under 75 preferred) Performance status: ECOG
0-3 (ECOG 0 or 1 preferred) Hematopoietic: (preferred) WBC at least 3,000/mm3 Platelet
count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) Hepatic:
(preferred) Bilirubin less than 2.0 mg/dL PT/PTT normal Renal: (preferred) Creatinine less
than 2.0 mg/dL Cardiovascular: (preferred) At least 6 months since prior myocardial
infarction No congestive heart failure, cardiac arrhythmia, or hypertension requiring
medication Pulmonary: (preferred) pO2 at least 60 mm Hg Reasonable respiratory reserve No
supplemental oxygen requirement Not dyspneic at rest Other: No chronic auto-coagulation
(preferred) No active infection No chronic underlying immunodeficiency disease (including
HIV, hepatitis B) No known autoimmune disease Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since prior radiotherapy (7 days since stereotactic radiosurgery) Surgery: At least 4
weeks since prior surgery to control brain metastases No prior organ transplantation

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert O. Dillman, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Biotherapy Research Group

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000064631

NCT ID:

NCT00002733

Start Date:

January 1996

Completion Date:

January 2000

Related Keywords:

  • Kidney Cancer
  • Melanoma (Skin)
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV renal cell cancer
  • stage IV melanoma
  • unspecified adult solid tumor, protocol specific
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Melanoma

Name

Location

Hoag Memorial Hospital PresbyterianNewport Beach, California  92658