Health Condition 1: null- Relapsed Solid Tumor Cancer
Conditions
Interventions
Intervention1: Genopep 1 (Issar 1): Multiple doses, 5 days of treatment period, Subcutaneous and Intravenous
Control Intervention1: NIL: NIL
Sponsors
ISSAR Pharmaceuticals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA: - Patients with histologically or cytologically confirmed diagnosis of any solid tumour. - Patients who have failed at least one or two lines of treatment or who have cancer that cannot be cured by any known treatment method. - Patients of either sex, aged between 18 and 75 years. - Performance status of 0 to 2 on the ECOG or Zubrod scale. - Clinically measurable or assessable disease with either progression at least within 6 months after first line chemotherapy (resistant disease) and/or recurrence of disease within 6 months of first line chemotherapy (recurrent disease) or conditions for which there exists no standard first line chemotherapy. - Estimated life expectancy of at least 12 weeks (as per the discretion of Principal Investigator). - Adequate bone marrow reserve: - WBC ≥4 x 109 /L - Platelets ≥100 x 109 /L - Haemoglobin ≥10 g/dl - Adequate liver function: - Bilirubin ≤ 1.5 mg/dl. - ALT/AST less than 3 times the ULN and if liver metastasis, less than 5 times the ULN. - Alkaline phosphatase less than 3 times the ULN and if liver metastasis, less than 5 times the ULN. Renal function: - Renal function: serum creatinine ≤ 1.5 mg/dl - Ejection fraction ≥ 50% or the institutional normal limit - If Female Patients: Child-bearing potential either terminated by surgery, radiation, or menopause, or attenuated by the use of an approved contraceptive method (Intrauterine device, birth control pills, or barrier device) during and for 3 months after trial. - Negative ß-HCG/urine dip-stick test prior to the study entry, where child-bearing potential is not terminated. - Patients should be able to comply with the study procedures and schedule. - Patients should be able to understand study information provided and give informed consent, after being explained by the study team. He/She must be aware of the experimental nature of the study, its potential benefits, side effects, risks and discomforts.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA - CNS metastasis (active or inactive). - Serious concomitant systemic disorders incompatible with the study (at the discretion of the Principal Investigator). - Patients should not have received hormonal therapy within 1 week, or undergone major surgery within 4 weeks, or radiotherapy and/or chemotherapy within 4 weeks prior study entry (6 weeks for nitrosoureas and/or mitomycin C). - Known hypersensitivity to Immunoglobins. - Radiotherapy to >25 % of bone marrow. - Subjects less than the age of 18 years. - Pregnant or breast feeding women. - Hypersensitivity and allergies to proteins/peptides - Currently enrolled in any other investigational drug study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To determine the MTD of GENOPEP 1 (ISSAR 1) 2. To determine the DLT of GENOPEP 1 (ISSAR 1) 3. To determine the OBD of GENOPEP 1 (ISSAR 1) Timepoint: End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the pharmacokinetics and pharmacodynamics of GENOPEP 1 (ISSAR 1) 2. To assess the safety of GENOPEP 1 (ISSAR 1) 3. To assess the efficacy of GENOPEP 1 (ISSAR 1) Timepoint: End of the Study | — |
Countries
India
Contacts
Public ContactDr R Srinivasarao
Department of Medical Oncology
Outcome results
None listed