Status:
TERMINATED
Treated Blood Cells, Cyclophosphamide, Fludarabine Phosphate, and Aldesleukin in Treating Patients With Cancer
Lead Sponsor:
Cancer Research UK
Conditions:
Breast Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 f...
Detailed Description
OBJECTIVES: Primary * To evaluate the feasibility of MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes in combination with preconditioning chemotherapy comprising cyclophosphamide and flu...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01212887
Start Date
August 1 2007
End Date
April 1 2010
Last Update
February 28 2012
Active Locations (1)
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1
Christie Hospital
Manchester, England, United Kingdom, M20 4BX