IL-2 Therapy in Lymphodepleted Patients With Metastatic Melanoma - Full Text View

Purpose

This study combines Interleukin-2, standard of care treatment for metastatic melanoma, with cyclophosphamide, fludarabine and GM-CSF to see if patients with metastatic melanoma will have improve response rates.

Condition	Intervention	Phase
Metastatic Melanoma	Drug: Interleukin-2 Drug: cyclophosphamide Drug: fludarabine Drug: GM-CSF	Phase II

MedlinePlus related topics:

Melanoma

ChemIDplus related topics:

Cyclophosphamide Fludarabine Fludarabine monophosphate Sargramostim Granulocyte-macrophage colony-stimulating factor Interleukin-2

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	DMS 0320: High Dose Interleukin-2 (IL-2) Therapy in "Lymphodepleted Primed" Patients With Metastatic Melanoma

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

To determine complete and partial response rate
To determine treatment feasibility (toxicity)
To determine the quality and quantity of lymphocyte recovery during and following treatment
To estimate the time to progression and survival of patients following treatment
To correlate the quality and quantity of lymphocyte recovery with clinical outcome

Estimated Enrollment:	33
Study Start Date:	February 2004
Estimated Study Completion Date:	August 2007

Detailed Description:

After meeting eligibility requirements, patients will have outpatient chemotherapy, cyclophosphamide for two days, fludarabine for five days, for a total of seven days. On the eighth day, patients will be admitted to the hospital and receive Interleukin-2 and GM-CSF. On the 22nd day, patients will be admitted to the hospital for a second course of Interleukin-2. Including a post-treatment evaluation, treatment may last up to 27 weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed metastatic melanoma with measurable disease
Patients must be at least 4 weeks from their last immunotherapy, radiation, surgery or chemotherapy (6 weeks for nitrosureas) and recovered from all ill effects
Karnofsky Performance Status greater than or equal to 60%
Life expectancy greater than or equal to 12 weeks
Adequate end organ function as defined in text of protocol
Women must not be pregnant or breastfeeding
Must agree to use appropriate contraception
Patient must be competent and must sign informed consent

Exclusion Criteria:

Patients may not have been treated previously with IL-2
Concomitant second malignancy except for non-melanoma skin cancer, and non-invasive cancer such as cervical CIS, superficial bladder cancer without local recurrence, breast CIS
In patients with a prior history of invasive malignancy, less than five years in complete remission
Positive serology for HIV, hepatitis B or hepatitis C
Significant co-morbid illness such as uncontrolled diabetes or active infection that would preclude treatment on this regimen
Use of corticosteroids or other immunosuppression (if patient had been taking steroids, at lease 4 weeks must have passed since the last dose)
History of autoimmune disease
Creatinine Clearance of less than 50ml/min

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225771

Locations


United States, New Hampshire
	Dartmouth-Hitchcock Medical Center
	Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Bayer

Chiron Corporation

Investigators


Principal Investigator:	Marc S Ernstoff, MD	Dartmouth-Hitchcock Medical Center

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	D0320
First Received:	September 22, 2005
Last Updated:	August 2, 2007
ClinicalTrials.gov Identifier:	NCT00225771
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:

Melanoma

Metastatic Melanoma

Interleukin-2

IL-2

Lymphodepletion

Study placed in the following topic categories:

Neuroectodermal Tumors

Interleukin-2

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Neuroepithelioma

Fludarabine

Fludarabine monophosphate

Cyclophosphamide

Nevus

Neuroendocrine Tumors

Melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Neoplasms, Nerve Tissue

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

Neoplasms

Sensory System Agents

Analgesics, Non-Narcotic

Therapeutic Uses

Myeloablative Agonists

Nevi and Melanomas

Peripheral Nervous System Agents

Analgesics

Antineoplastic Agents, Alkylating

Antirheumatic Agents

Central Nervous System Agents

Alkylating Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Dartmouth-Hitchcock Medical Center Bayer Chiron Corporation
Information provided by:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00225771