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T-cell Based Immunotherapy for of Melanoma

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

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
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.

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

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 identifier: NCT00937625

Contact: Inge Marie Svane, Professor, MD +45 38683868
Contact: Rikke Andersen, MD +45 38683868

Department of Oncology, Copenhagen University Hospital, Herlev Recruiting
Herlev, Denmark, 2730
Contact: Inge Marie Svane, Professor, MD    +45 38683868   
Contact: Rikke Andersen, MD    +45 38683868   
Principal Investigator: Rikke Andersen, MD         
Sponsors and Collaborators
Inge Marie Svane
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 Identifier (NCT Number):
Responsible Party: Inge Marie Svane, Professor, Herlev Hospital 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:
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Fludarabine phosphate
Alkylating Agents
Analgesics, Non-Narcotic
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Central Nervous System Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 27, 2015