Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019942

Purpose

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Treating a patient's white blood cells with interleukin-2 may stimulate them to kill tumor cells.

PURPOSE: This phase II trial is studying how well giving chemotherapy together with biological therapy works in treating patients with metastatic melanoma that has not responded to previous therapy.

Condition	Intervention	Phase
Melanoma (Skin)	Biological: aldesleukin Drug: cyclophosphamide Drug: fludarabine phosphate	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Treatment of Patients With Metastatic Melanoma Using Cloned Lymphocytes Following the Administration of a Nonmyeloablative But Lymphocyte Depleting Regimen

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine monophosphate Aldesleukin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Clinical tumor regression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Survival [ Designated as safety issue: No ]
Long-term immune status [ Designated as safety issue: No ]
Clinical response [ Designated as safety issue: No ]
Impact of administering infused cells without filgrastim (G-CSF) [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	September 1999
Estimated Primary Completion Date:	September 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohorts 1 and 2 (phase I): Experimental Patients receive increasing doses of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 without IL-2.	Drug: cyclophosphamide Given IV Drug: fludarabine phosphate Given IV
Cohort 3 (phase I): Experimental Patients receive the maximum tolerated dose (MTD) of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 followed by low-dose IL-2 IV over 15 minutes every 8 hours on days 1-45 for 6 weeks.	Biological: aldesleukin Given IV Drug: cyclophosphamide Given IV Drug: fludarabine phosphate Given IV
Cohort 4 (phase I): Experimental Patients receive the MTD of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1 followed by high-dose IL-2 IV over 15 minutes every 8 hours on days 1-3.	Biological: aldesleukin Given IV Drug: cyclophosphamide Given IV Drug: fludarabine phosphate Given IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of metastatic melanoma that is refractory to therapy
Evaluable disease

PATIENT CHARACTERISTICS:

Age

16 and over

Performance status

ECOG 0-1

Life expectancy

More than 3 months

Hematopoietic

Absolute neutrophil count greater than 1,000/mm^3
Platelet count greater than 100,000/mm^3
Hemoglobin greater than 8.0 g/dL
No coagulation disorder

Hepatic

Bilirubin no greater than 1.6 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome)
AST/ALT less than 2 times upper limit of normal
Hepatitis B surface antigen negative

Renal

Creatinine no greater than 1.6 mg/dL

Cardiovascular

No major medical illness of the cardiovascular system

Pulmonary

No major medical illness of the respiratory system

Other

No major medical illness of the immune system
No active systemic infection
HIV negative
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception during and for 4 months after study participation
Must sign a durable power of attorney

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

No concurrent steroid therapy

Radiotherapy

Not specified

Surgery

Not specified

Other

More than 4 weeks since any prior therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019942

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Patient Recruitment 866-820-4505

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven A. Rosenberg, MD, PhD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

Publications:

Dudley ME, Wunderlich JR, Robbins PF, Yang JC, Hwu P, Schwartzentruber DJ, Topalian SL, Sherry R, Restifo NP, Hubicki AM, Robinson MR, Raffeld M, Duray P, Seipp CA, Rogers-Freezer L, Morton KE, Mavroukakis SA, White DE, Rosenberg SA. Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes. Science. 2002 Oct 25;298(5594):850-4. Epub 2002 Sep 19.

Responsible Party:	NCI - Surgery Branch ( Steven A. Rosenberg )
Study ID Numbers:	CDR0000067331, NCI-99-C-0158, NCI-T99-0078
Study First Received:	July 11, 2001
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00019942 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Vidarabine
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Cyclophosphamide
Melanoma
Anti-Retroviral Agents
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Nevi and Melanomas

Alkylating Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Fludarabine monophosphate
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Aldesleukin
Myeloablative Agonists
Fludarabine
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009