Health Condition 1: null- Patients with a histologically confirmed diagnosis of ovarian cancer, prostate cancer,metastatic adenocarcinoma of the lung and colorectal carcinoma. Age: 18 to 75 years
Conditions
Interventions
Intervention1: APCEDEN: It is an autologous dendritic cell based cellular
immunotherapy product provisionally approved to be used in
patients with refractory prostate, colorectal, ovarian or lung
canc
Sponsors
APAC Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with a histologically confirmed diagnosis of Prostate, Ovarian, Colo-rectal and Lung cancer. 2.As per the physician the cancer should be refractory to at least 2/3 prior therapies, with measurable disease. 3.Karnofsky status >= 70% and/or WHO/ECOG (Eastern Cooperative Oncology Group) performance status 0-2 4.Life expectancy >= 3 months 5.Patient to have adequate venous access(to undergo leukapheresis) 6.No known hypersensitivity to APCEDEN® or any of its constituents. 7.Three or fewer bone metastases on a bone scan with minimal symptoms. 8.No lymph node lesions greater than 3.0 cm at longest diameter. 9.Adequate hematological, hepatic and renal function. 10.Normal organ function and normal hematological parameters; laboratory parameters should be within normal range, except following laboratory parameters: HEMOGLOBIN >= 10 G/DL; GRANULOCYTES >= 1,500/µL; LYMPHOCYTES >= 1000/µL; PLATELETS >= 100,000/µL; SERUM CREATININ 11.No prior history of a serious autoimmune disorder 12.No concomitant medication with immune suppressive drugs 13.No brain metastases leptomeningeal involvement (other than astrocytomas) 14.No clinically significant pleural effusion 15.No complete tumor obstruction (e.g., bronchus, ureter, or bowel) 16.Patient should not be taking concurrent corticosteroids as these may subside the immune function and interfere with immunotherapy response. 17.Patient should be able to adhere to the study visit schedule and other protocol requirements
Exclusion criteria
Exclusion criteria: 1.History of other active malignancy. 2.Prior chemotherapy, radiation therapy, immunosuppressive or investigational therapy for metastatic disease in previous 12 months. 3.Strong opioids, immunosuppressives, megestrol acetate or other estrogenic hormones within 1 month prior to enrollment. 4.Brain, liver, or lung metastases; uncontrolled heart, liver, lung, or renal diseases or other serious illness. 5.Prior splenectomy. 6.History of moderate to severe lower limb lymphedema, or recent signs of deep venous thrombosis (DVT) or thrombo-embolic disease, or impending stroke. 7.History of immunodeficiency or autoimmune disease; positive HIV, HbsAg or anti-HCV. 8.Impending untreated spinal cord compression or urinary outlet obstruction. 9.Any medication that might affect immune function. (Exceptions: Nonprescription doses of NSAIDS; acetaminophen or aspirin; low doses of antihistamine therapy; normal range doses of vitamins; and H2 blockers). 10.Pregnant or lactating women. 11.Known positive for hepatitis B or C or HIV. 12.Underlying cardiac disease associated with myocardial dysfunction that requires active medical treatment, or unstable angina related to atherosclerotic cardiovascular disease, or under treatment for arterial or venous peripheral vascular disease 13.Diagnosis of any other invasive cancer which is considered to be life-threatening within the next five years, and/or taking anti-cancer therapy for cancer other than ovarian (such as continuation of hormonal therapy for breast cancer diagnosed more than five years earlier). 14.Active infection or other active medical condition that could be eminently life-threatening, including active blood clotting or bleeding diathesis. 15.Prior splenectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Overall Survival 2. Evaluation of objective response through Immune related Response Criteria (irRC): measure of PD; PR and SD. 3. Immune response as assessed through Treg population and serum IFN-γ levels 4. Monitor treatment emergent adverse events. Timepoint: 1. Overall Survival 2. Evaluation of objective response through Immune related Response Criteria (irRC): measure of PD; PR and SD. 3. Immune response as assessed through Treg population and serum IFN-γ levels 4. Monitor treatment emergent adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life as assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) 2. Evaluation of tumour response as per RECIST. Monitor for evidence of the following tumor responses: Overall response rate (ORR), time to progression (TPP); Progression free survival (PFS) and Disease free survival (DFS) 3. To explore the correlation between APCEDEN® immune response and overall survival. Timepoint: Dose1 Day 1 - QOL (FACT-G), Response evaluation using RECIST Dose 2 Day 15 - QOL (FACT-G) Dose 3 Day 30 - QOL (FACT-G) Dose 4 Day 45 - QOL (FACT-G) Dose 5 Day 60 - QOL (FACT-G) Dose 6 Day 75 -QOL (FACT-G) Post treatment (6 weeks) Day 117 - QOL (FACT-G), Response evaluation using RECIST | — |
Countries
India
Contacts
Public ContactDr Bandana Sharan
APAC Biotech Pvt Ltd.
Outcome results
None listed