A Pilot Study to Evaluate Safety and Efficacy of HLA-mismatched Granulocyte Transfusions in the Treatment of Patients with Solid Malignant Tumors Who Are Resistant to Standard Cancer Therapy or for Whom No Standard Cancer Therapy Exists
- Conditions
- Health Condition 1: null- CANCER
- Registration Number
- CTRI/2012/11/003116
- Lead Sponsor
- Munogenics Inc USA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 22
1. Ability to understand and willingness to sign a written informed consent document.
2. All patients must have histologically or cytologically confirmed solid malignant tumors for which standard curative do not exist or are no longer effective.
3. Subjects with measurable disease i.e. lesions that can be accurately measured in at least one dimension (longest diameter recorded) as more than 20 mm with conventional technique or as more than 10 mm with spiral CT scan.
4. More than 4 weeks should have elapsed since prior cytotoxic therapy, radiation therapy, and major surgery and have recovered completely from adverse effects of any prior medical therapy, radiation therapy, and surgery
5. ECOG Performance status of more than or equal to 2.
6. Subjects must have adequate organ function, such as Hb>= 8g/dl, absolute neutrophils >=1,000/µl, platelet transfusion independent, platelet count >=100,000/µl, serum bilirubin <=2 mg/dl, AST/ALT less than 3xULN and serum creatinine <=2 mg/dl.
7. Life expectancy of at least 4 months.
8. Non-pregnant and non-nursing.
9. Women and men of reproductive potential should agree to use an effective means of birth control.
10. Women at the reproductive age should have a negative serum or urine pregnancy test before treatment.
11. Negative panel reactive antibody test (absence of serum HLA Class I and II antibodies).
1)Uncontrolled diabetes mellitus, significant cardiac disease e.g. recent myocardial infarction (within 30 days) or active serious infection.
2)Subjects with evidence of brain tumors or brain metastases at the time of screening.
3)Subjects who have received any other investigational drug within 30 days prior to day-1 of granulocyte infusion.
4)Known HIV infection.
5)Recent use (within 30 days) of immunosuppressive agents other than steroids.
6)Prior history of stem cell transplantation.
7)Prior history of fludarabine therapy.
8)Any condition, including laboratory abnormalities, that in the opinion of the investigator places the subject at an unacceptable risk or deems the subject not suitable for participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess response to treatment (complete response, partial response, stable disease and progression) as per CT scans (using RECIST criteria) done at 90-100 days after last transfusion as compared to tumor measurements at baseline.Timepoint: To assess response to treatment (complete response, partial response, stable disease and progression) as per CT scans (using RECIST criteria) done at 90-100 days after last transfusion as compared to tumor measurements at baseline.
- Secondary Outcome Measures
Name Time Method To determine the safety, dose response and tolerance of irradiated white cell intravenous infusions given daily up to a total white cell dose of 2x100000000000 cells.Timepoint: Baseline, weekly visits (1-12), 90-100 days post transfusion