Fludarabine Followed By Adoptive Immunotherapy in Treating Patients With Stage IV Melanoma

NCT00317759 | Completed Phase 1

• 3 other identifiers: 1796.00FHCRC-1796.00CDR0000327817
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies such as cellular adoptive immunotherapy use different ways to stimulate the immune system and stop cancer cells from growing. Fludarabine may help the immune system kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of fludarabine followed by cellular adoptive immunotherapy in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

therapeutic autologous lymphocytes BIOLOGICAL

fludarabine phosphate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Stage IV disease * HLA-A2 or -A3-expressing disease * Bidimensionally measurable residual disease by palpation or radiographic imaging (e.g., x-ray or CT scan) * No CNS metastases * Previously treated CNS involvement allowed provided there is no evidence of CNS disease at least 2 months after completion of therapy PATIENT CHARACTERISTICS: Age * 18 to 75 Performance status * Karnofsky 80-100% Life expectancy * More than 6 months Hematopoietic * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count \> 2,000/mm\^3 Hepatic * SGOT no greater than 3 times upper limit of normal * Bilirubin no greater than 1.6 mg/dL * INR no greater than 1.5 times normal Renal * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular * No congestive heart failure * No clinically significant hypotension * No symptoms of coronary artery disease * No cardiac arrhythmia by EKG requiring drug therapy Pulmonary * No clinically significant pulmonary dysfunction * FEV\_1 at least 1.0 L\* * DLCO at least 45%\* NOTE: \*For patients with a history of pulmonary dysfunction Immunologic * No active infection * No oral temperature greater than 38.2°C within the past 48 hours * No systemic infection requiring chronic maintenance or suppressive therapy Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy (e.g., interleukins, interferons, melanoma vaccines, IV immunoglobulins, expanded polyclonal tumor-infiltrating lymphocytes, or lymphokine-activated killer therapy) Chemotherapy * At least 3 weeks since prior chemotherapy (standard or experimental) Endocrine therapy * No concurrent steroids Radiotherapy * At least 3 weeks since prior radiotherapy Surgery * Not specified Other * At least 3 weeks since prior immunosuppressive therapy * No concurrent pentoxifylline * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

• Wallen H, Thompson JA, Reilly JZ, Rodmyre RM, Cao J, Yee C. Fludarabine modulates immune response and extends in vivo survival of adoptively transferred CD8 T cells in patients with metastatic melanoma. PLoS One. 2009;4(3):e4749. doi: 10.1371/journal.pone.0004749. Epub 2009 Mar 9.

  PMID: 19270751 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

fludarabine phosphate

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Cassian Yee, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2006
• First Posted: April 25, 2006
• Study Start: May 1, 2003
• Study Completion: October 1, 2008
• Last Updated: October 1, 2015

Record last verified: 2010-05

Locations

US (1)