Phase 2 N=26 Randomized Treatment

Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma

Melanoma (Skin)

Bottom Line

View on ClinicalTrials.gov: NCT00096382 ↗

Enrolled (actual)

Serious AEs

16.0%

Results posted

Mar 2013

Primary outcome: Primary: Clinical Tumor Regression — 1; 1; 9; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: aldesleukin (Biological); filgrastim (Biological); therapeutic tumor infiltrating lymphocytes (Biological); cyclophosphamide (Drug); fludarabine phosphate (Drug); radiation therapy (Radiation)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institutes of Health Clinical Center (CC)
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Tumor Regression	1; 1; 9; 2	—
PRIMARY Safety	23; 3	—

Summary

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. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Autologous stem cell transplant may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Interleukin-2 may stimulate a person's lymphocytes to kill tumor cells. Combining chemotherapy, radiation therapy, and biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cyclophosphamide and fludarabine together with radiation therapy followed by cellular adoptive immunotherapy, autologous stem cell transplant, and interleukin-2 works in treating patients with metastatic melanoma.

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of metastatic melanoma
Measurable disease
Resected or stable brain metastases are allowed

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy

At least 3 months

Hematopoietic

See Immunologic
Absolute neutrophil count > 1, 000/mm^3 (without support of filgrastim [G-CSF])
Platelet count > 100,000/mm^3
Hemoglobin ≥ 8 g/dL (transfusion allowed)
No coagulation disorders

Hepatic

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 1,000/mm^3
No opportunistic infections
Human Immunodeficiency virus (HIV) negative
Epstein-Barr virus positive

Other

Not pregnant or nursing
Fertile patients must use effective contraception during and for 4 months after study treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics

Chemotherapy

At least 6 weeks since prior nitrosourea therapy
No prior cyclophosphamide and fludarabine as part of a preparative regimen on National Cancer Institute (NCI) Surgery Branch adoptive cell therapy studies unless sufficient numbers of CD34+ stem cells (more than 2 x10^6/kg patient weight) have been obtained prior to the administration of chemotherapy

Endocrine therapy

No concurrent systemic steroid therapy

Radiotherapy

Not specified

Surgery

See Disease Characteristics
Prior minor surgery within the past 3 weeks allowed if recovered

Other

Recovered from all prior therapy
At least 30 days since prior systemic therapy
No other concurrent experimental agents

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00096382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.