A Pilot Study of Radiation-Immune Cell Combination Therapy in Cervical Cancer

NCT01194609 | Terminated Phase 1 DMC

• 1 other identifier: RadImmune Cx-1001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Among the immune cell therapy, autologous adoptive immune cell therapy is a method to transfer the immune cells derived from peripheral white blood cells and expanded and stimulated with various cytokines and tumor specific antigens in cancer patients. Recently, the low-dose radiation is known to increase the immune response in many human cancer patients. In a clinical trial, 70% response rate with combination of low-dose radiation and adoptive immune cell therapy was reported in recurrent melanoma patients. This study is to investigate the feasibility of combination of low-dose radiation and autologous immune cell therapy in recurrent cervical cancer which is resistant to conventional palliative treatment.

Conditions

Uterine Cervical Neoplasms

Keywords

Low dose radiation; Adoptive immune cell therapy; Cervical cancer; Pilot study

Outcome Measures

Primary Outcomes (1)

• Response rate

  Response rate according to RECIST criteria for 12 months

  12months

Secondary Outcomes (1)

• Toxicity

  12months

Study Arms (1)

Low dose radiation, Immune cell therapy

EXPERIMENTAL

Combination treatment of low-dose radiation 20cGy every 3 weeks three times and autologous immune cell therapy 2 consecutive weeks 3 times every 3 weeks

Biological: Immune cell; Radiation: Low dose radiation

Interventions

Immune cell BIOLOGICAL

InnoLak two consecutive weeks every 3 weeks for 3 times

Also known as: InnoLAK

Low dose radiation, Immune cell therapy

Low dose radiation RADIATION

20cGy whole body radiation every three weeks for three times

Also known as: Whole body radiation

Low dose radiation, Immune cell therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have signed an approved informed consent and authorization permitting release of personal health information.
• Age 18-75 years
• Pathologically proven recurrent or persistent cervical cancer patients resistant to conventional palliative chemotherapy or radiation therapy
• Persistent tumor more than 1cm after initial chemoradiation or radiation therapy
• Persistent tumor more than 1cm after chemoradiation, radiation or chemotherapy in recurrent cervical cancer
• Metastatic cervical cancer to lung resistant to conventional chemotherapy
• ECOG performance status 0, 1, 2.
• Expected survival more than 3 months
• Patients must have adequate:
• Hematologic function: ANC ≥ 1,500/mcl, Hemoglobin \>10g/dL, platelets ≥ 100,000/mcl Renal function: creatinine ≤ 1.5 x ULN Hepatic function: AST, ALT ≤ 1.5 x ULN,
• More than 3 weeks from the last day of previous chemotherapy or radiation

You may not qualify if:

• Patients with immune disease or auto-immune disease (ex. rheumatoid arthritis, SLE, immune vasculitis, IDDM)
• Immune deficiency disease
• Cancers other than cervical cancer within 5 years
• Acute myocardial infarction, uncontrolled hypertension
• Severe allergic disease
• Severe psychotic disease
• Those who can be a candidate for curative surgery

Sponsors & Collaborators

• Korea Cancer Center Hospital: lead

Study Sites (1)

Sang-Young Ryu

Seoul, Nowon-Gu, 139-706, South Korea

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiation; Whole-Body Irradiation

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Radiotherapy; Therapeutics; Investigative Techniques

Study Officials

• Sang-Young Ryu, MD

  Korea Institute of Radiological & Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A staff at department of obstetrics and gynecology

Study Record Dates

• First Submitted: September 2, 2010
• First Posted: September 3, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 9, 2014

Record last verified: 2014-05

Locations

KR (1)