Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief summary
RATIONALE: Biological therapies, such as TNF-bound colloidal gold, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of TNF-bound colloidal gold in treating patients with advanced solid tumors.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) in patients with advanced solid tumors. * Determine the toxicities of CYT-6091 in these patients. Secondary * Determine the pharmacokinetics of CYT-6091 in these patients. * Evaluate biopsy samples of tumor and adjoining normal tissue for levels of CYT-6091. * Determine if antitumor effects of CYT-6091 occur in these patients. OUTLINE: This is an open-label, sequential cohort, dose-escalation study. Patients receive TNF-bound colloidal gold (CYT-6091) IV on days 1 and 15 (course 1). Approximately 4-6 weeks later, patients are re-staged and responding patients may receive another course of therapy. Patients may receive up to 3 re-treatment courses. Cohorts of 3-6 patients receive escalating doses of CYT-6091 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. Blood samples are collected at baseline and periodically during the first course of therapy for pharmacokinetic and pharmacodynamic analyses. After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for the next year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Advanced and/or metastatic disease * Unresponsive to conventional therapy (i.e., disease progressed while receiving any known standard curative or palliative therapy) OR previously untreated tumor for which no standard treatment exists * Measurable or evaluable metastatic disease * No lymphoma or other hematologic malignancy * No known brain metastases * Previously treated brain metastases with no evidence of recurrence allowed PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 2.5 mg/dL * ALT and AST ≤ 1.5 times upper limit of normal (ULN) (3 times ULN if liver metastases are present) * Alkaline phosphatase ≤ 1.5 times ULN (3 times ULN if liver metastases are present) * Prothrombin time ≤ 1.5 times ULN * Hemoglobin ≥ 10.0 g/dL (transfusion allowed) * LVEF ≥ 45% by echocardiogram or thallium stress test for patients \> 50 years of age or history of cardiovascular disease * FEV\_1 and DLCO \> 30% of predicted for patients with a history of pulmonary disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active bacterial or viral infection with systemic manifestations (e.g., fever, symptoms, leukocytosis) * Localized chronic infections, such as mild acne or tinea pedis allowed * No acute or chronic viral hepatitis * No known bleeding disorder * No other concurrent life-threatening illness, including any of the following: * Unstable angina * Severe oxygen-dependent chronic obstructive pulmonary disease * End-stage liver disease * No known active renal disease or renal insufficiency as evidenced by serum creatinine \> 2.0 mg/dL * No HIV positivity PRIOR CONCURRENT THERAPY: * Recovered from prior therapy * More than 3 weeks since prior biological or cytotoxic agents (6 weeks for nitrosoureas) * No known requirment for palliative treatment * No concurrent surgery * No other concurrent anticancer therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose of TNF-bound colloidal gold (CYT-6091) | — |
| Toxicity | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurements of CYT-6091 in tumor biopsies | — |
| Tumor biopsy histology and gene expression after treatment | — |
| Immunogenicity of CYT-6091 | — |
| Duration of stable disease | — |
| Response of target and nontarget lesions | — |
| Overall response | — |
| Duration of response | — |
| Electron microscopy of biopsy to determine presence of colloidal gold | — |
| Pharmacokinetic profile of CYT-6091 | — |
Countries
United States