APCEDEN? (Autologous Dendritic Cell Therapy) In Refractory Solid Tumors.

Phase 2

Completed

• Conditions: Health Condition 1: null- Cancer

• Registration Number: CTRI/2011/07/001917
• Lead Sponsor: APAC BIOTECH PVTLTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Male and female subjects from 18 to 70 years of age

2.Histologically confirmed refractory solid tumors on symptomatic care

3.Available tumor tissue: embedded in paraffin blocks and/or unstained slides

4.Life expectancy at least 3 months

5.ECOG status less than 2

6.Adequate Organ function:

A.Liver function:

i.In the absence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 2 times ULN

ii.In the presence of disease involvement in the liver and if bilirubin less than equal to 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be less than equal to 5 times ULN

iii.Alkaline phosphatase less than equal to 2.5 times ULN

iv. Albumin more than equal to 3.0 g/dL

B.Renal function:

i.Serum creatinine less than equal to 1.5 times ULN

ii.No active acute or chronic urinary tract infection

iii.Urinalysis with no evidence of proteinuria

C.Hematology Status:

i.Platelet count more than equal to 100,000 platelet/cumm (100 ×109/L)

ii.Hemoglobin more than equal to 9 g/dL.

iii.WBC more than equal to 3,000/cumm

D.Coagulation Profile:

i.Acceptable coagulation profile (PT or INR, PTT) less than 1.5 times ULN

E.Serum immune-globulins IgA and IgM within normal range

7.No blood transfusion within 4 weeks of joining the study.

8.No exposure to immunotherapy and cancer Immunotherapy

9.Females of child bearing potential must have negative urine pregnancy test at screening

10.Child bearing potential participants to exercise effective birth control measures

11.Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site.

Exclusion Criteria

1.Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment

2.Exposure to any investigational agent within 30 days of the Screening Visit.

3.Central Nervous System Metastases

4.Known Autoimmune disease or disease process that involves the use of immunosuppressive therapy

5.Patients on long-term steroid therapy (more than one week)

6.Underlying Cardiac disease associated with New York Heart Association Class III and IV function or unstable angina related to atherosclerotic cardiovascular disease

7.Active infection or other active medical condition that could be eminently life threatening, including no active blood clotting or bleeding diathesis

8.Known HIV infection

9.Active Hepatitis

10.Active Tuberculosis

11.Any Uncontrolled active, infection.

12.Substance abuse or any condition that might interfere with the subject?s participation in the study or in the evaluation of the study results.

13.History of hypersensitivity to Immunotherapy such as asthma, anaphylaxis or other severe reactions

14.Any medical, psychological, sociological or geographical constraints judged by the investigator that would impede patients compliance to the study procedures

Study & Design

• Study Type: Interventional
• Study Design: Not specified