T-cell Based Immunotherapy for of Melanoma
This study is currently recruiting participants.
Verified November 2011 by Herlev Hospital
Sponsor:
Inge Marie Svane
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00937625
First received: July 10, 2009
Last updated: November 22, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | 14 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Fludarabine, Fludara®, Bayer Shering
- Interleukin-2, Proleukin®, Chiron B.V.
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937625
Contacts
| Contact: Inge Marie Svane, Professor, MD | +4544884488 | imsv@heh.regionh.dk |
| Contact: Eva Ellebæk, MD | +4544884488 | evaell02@heh.regionh.dk |
Locations
| Denmark | |
| Department of Oncology, Copenhagen University Hospital, Herlev | Recruiting |
| Herlev, Denmark, 2730 | |
| Contact: Inge Marie Svane, Professor, MD +4544884488 imsv@heh.regionh.dk | |
| Contact: Eva Ellebæk, MD +4544884488 evaell02@heh.regionh.dk | |
| Principal Investigator: Eva Ellebæk, 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: | November 22, 2011 |
| 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 May 16, 2013