T-cell Based Immunotherapy for of Melanoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Herlev Hospital
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00937625
First received: July 10, 2009
Last updated: December 22, 2013
Last verified: December 2013
  Purpose

The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.

Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.

After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)


Condition Intervention Phase
Melanoma
Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. A Pilot Study.

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • toxicity [ Time Frame: week 0 to 20 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immune response [ Time Frame: week 0 to 20 ] [ Designated as safety issue: No ]
  • tumor response [ Time Frame: week 8 and every 3rd week until progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: June 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2
    Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.
    Other Names:
    • Cyclophosphamide, Sendoxan®, Baxter A/S
    • Fludarabine, Fludara®, Bayer Shering
    • Interleukin-2, Proleukin®, Chiron B.V.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.

Exclusion Criteria:

  • Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937625

Contacts
Contact: Inge Marie Svane, Professor, MD +45 38683868 inge.marie.svane@regionh.dk
Contact: Rikke Andersen, MD +45 38683868 rikke.andersen.02@regionh.dk

Locations
Denmark
Department of Oncology, Copenhagen University Hospital, Herlev Recruiting
Herlev, Denmark, 2730
Contact: Inge Marie Svane, Professor, MD    +45 38683868    inge.marie.svane@regionh.dk   
Contact: Rikke Andersen, MD    +45 38683868    rikke.andersen.02@regionh.dk   
Principal Investigator: Rikke Andersen, MD         
Sponsors and Collaborators
Inge Marie Svane
Investigators
Study Director: Inge Marie Svane, Professor, MD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
  More Information

No publications provided by Herlev Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00937625     History of Changes
Other Study ID Numbers: MM0909
Study First Received: July 10, 2009
Last Updated: December 22, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Fludarabine monophosphate
Fludarabine
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 26, 2014