Indomethacin Plus Biological Therapy in Treating Patients With Advanced Melanoma

NCT00002535 | Completed Phase 2

• 3 other identifiers: STLMC-BRM-93004CDR0000078467NCI-V93-0295
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining biological therapies with indomethacin and cyclophosphamide may kill more tumor cells. PURPOSE: Phase II trial to compare the effectiveness of indomethacin and biological therapy with or without cyclophosphamide in treating patients who have advanced melanoma that has not responded to previous therapy.

Conditions

Melanoma (Skin)

Keywords

stage III melanoma; stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

lymphokine-activated killer cells BIOLOGICAL

therapeutic tumor infiltrating lymphocytes BIOLOGICAL

cyclophosphamide DRUG

indomethacin DRUG

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically documented melanoma that is metastatic or unresectable and unresponsive to conventional chemotherapy and/or radiotherapy Measurable or evaluable disease required Measurable disease defined as bidimensionally measurable lesion on physical exam, x-ray, or MRI Evaluable disease defined as: Unidimensionally measurable lesion on x-ray, scan, or photograph Disease assessable by serial chemistries, tumor markers, or nonspecific scans Disease assessable by functional manifestations (e.g., change in performance status, 10% or greater change in weight) Previously irradiated lesion with subsequent disease progression documented Bone-only lesions may be considered evaluable (lytic lesion on x-ray or bone scan should be followed) No metastases on CT or MRI involving more than 50% of the liver No uncontrolled or untreated CNS metastases PATIENT CHARACTERISTICS: Age: Over 16 Performance status: ECOG 0 or 1 Life expectancy: At least 3 months Hematopoietic: (unless tumor involvement of bone marrow or spleen is documented) WBC at least 3,500/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11.5 g/dL No significant hematologic abnormalities Hepatic: (unless tumor involvement of liver is documented) Bilirubin no greater than 1.6 mg/dL SGOT no greater than 150 U/L PT at least 1.5 times control PTT less than 1.5 times control Renal: (unless tumor involvement of kidney is documented) Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 50 mL/min Calcium no greater than 12 mg/dL No symptomatic hypercalcemia Cardiovascular: No myocardial infarction within 6 months No congestive heart failure No edema No hypotension or hypertension No coronary artery disease No history of arrhythmia No contraindication to the use of pressor agents Pulmonary: FEV1 at least 65% of predicted Other: No significant organ dysfunction No uncontrolled bacterial, viral, or fungal infection No active peptic or duodenal ulcer No psychiatric or seizure disorder No prior solid organ allograft HIV and hepatitis B surface antigen seronegative within 6 months of study entry No second malignancy within 5 years except: Inactive nonmelanomatous skin cancer Carcinoma in situ of the cervix No other serious illness that would limit survival to less than 2 years Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: More than 4 weeks since immunotherapy Chemotherapy: Prior anthracyclines allowed provided no symptomatic heart disease is present More than 4 weeks since chemotherapy (at least 2 weeks, with recovery, if disease progression is documented) More than 6 weeks since nitrosoureas, melphalan, or mitomycin Endocrine therapy: More than 1 week since corticosteroids (except physiological doses for respiratory ailments or adrenal insufficiency) Radiotherapy: More than 4 weeks since radiotherapy (at least 2 weeks, with recovery, if disease progression is documented) Surgery: More than 3 weeks since major surgery (excluding surgery for tumor collection)

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

Sponsors & Collaborators

• St. Luke's Medical Center: lead

Study Sites (1)

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; Cyclophosphamide; Indomethacin

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John P. Hanson, MD

  St. Luke's Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: July 29, 2004
• Study Start: July 1, 1993
• Study Completion: July 1, 2004
• Last Updated: June 26, 2013

Record last verified: 2000-08

Locations

US (1)