Treated Blood Cells, Cyclophosphamide, Fludarabine Phosphate, and Aldesleukin in Treating Patients With Cancer

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Placing a gene into T cells may improve the body's ability to recognize cancer cells and build an immune response to fight cancer. Drugs used in chemotherapy, such as cyclophosphamide and fludarabine phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapies, such as aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Giving specially treated T cells together with cyclophosphamide, fludarabine phosphate, and aldesleukin may kill more tumor cells.

PURPOSE: This phase I clinical trial is studying the side effects and best dose of treated T cells when given together with cyclophosphamide, fludarabine phosphate, and aldesleukin in treating patients with cancer.

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

Details

• Lead Sponsor: Cancer Research UK
• Treatments: Aldesleukin; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Vidarabine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed malignancy

• Metastatic or unresectable disease

• Standard curative or palliative measures do not exist, are no longer effective, have been completed, or have been refused

• CEA-positive tumor (either by immunohistochemistry or as demonstrated by elevated CEA > 50 μg/L)

• No primary brain tumor or brain metastases

PATIENT CHARACTERISTICS:

• WHO performance status 0-1

• Life expectancy ≥ 3 months

• Hemoglobin ≥ 10 g/dL

• Platelet count ≥ 100 x 10^9/L

• Neutrophil count ≥ 2.0 x 10^9/L

• Lymphocyte count ≥ 1.0 x 10^9/L

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT/AST ≤ 5 times ULN

• Alkaline phosphatase ≤ 5 times ULN

• Calculated creatinine clearance OR isotope clearance measurement ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy (male patients must use barrier-method contraception)

• LVEF ≥ 50% on MUGA scan (for patients receiving cyclophosphamide)

• ECG and exercise ECG (or stress ECHO) normal (may be abnormal but not clinically significant)

• Urine dipstick normal (may be abnormal but not clinically significant)

• No medical high risk due to nonmalignant systemic disease including active uncontrolled infection

• No known serologically positive hepatitis B, hepatitis C, HIV, or HTLV

• No history of autoimmune disease

• No inflammatory bowel disease

• No concurrent congestive heart failure or prior history of NYHA class III-IV cardiac disease

• No concurrent malignancies originating from other primary sites, except for adequately treated cone-biopsied carcinoma in situ of the cervix uteri or basal cell or squamous cell carcinoma of the skin

• No other condition that, in the investigator's opinion, would make the patient an unsuitable candidate for the clinical trial

PRIOR CONCURRENT THERAPY:

• At least 30 days since prior and no concurrent participation in another clinical trial

• At least 4 weeks since prior and no concurrent radiotherapy (except for palliative reasons [i.e., control of bone pain])

• At least 4 weeks since prior and no concurrent endocrine therapy, immunotherapy, or chemotherapy (6 weeks for nitrosoureas and mitomycin C)

• No toxic manifestations of previous treatment, except for alopecia or certain grade 1 toxicities that, in the opinion of the investigator and CRUK (Cancer Research UK), would exclude the patient (e.g., grade 1 neuropathy or grade 1 fatigue)

• No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered

• No prior bone marrow transplant or extensive radiotherapy to > 25% of bone marrow

• No concurrent systemic steroids or other immunosuppressive therapy

• No other concurrent anticancer therapy or investigational drugs