Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors

NCT00084812 | Completed Phase 1

• 2 other identifiers: 04-002MSKCC-04002
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment

  2 years

Secondary Outcomes (1)

• Response as assessed by RECIST criteria during 3-6 weeks of treatment

  2 years

Study Arms (1)

Safingol and Cisplatin

EXPERIMENTAL

Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days\* in the absence of disease progression or unacceptable toxicity. NOTE: \*Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration. Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.

Drug: cisplatin; Drug: safingol

Interventions

cisplatin DRUG

Safingol and Cisplatin

safingol DRUG

Safingol and Cisplatin

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Locally advanced or metastatic disease * Refractory to standard therapy OR not amenable to standard therapy * No known CNS metastasis or CNS primary PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * At least 12 weeks Hematopoietic * Neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * WBC count ≥ 3,500/mm\^3 * Hemoglobin ≥ 9.5 g/dL * Haptoglobin ≥ 30 mg/dL * No concurrent hemolysis or history of non-drug-induced hemolysis (e.g., spherocytosis) Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Bilirubin ≤ 1.5 mg/dL * PT and PTT normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * No cardiac arrhythmias * No congestive heart failure * No myocardial infarction within the past 6 months Other * Not pregnant * Negative pregnancy test * No nursing during and for at least 2 months after study participation * Fertile patients must use effective contraception during and for at least 2 months after study participation * HIV negative * No mental incapacity that would preclude giving informed consent * No moderate-to-severe high-frequency hearing loss * No persistent severe (grade 2) drug-induced peripheral neuropathy * No known allergy to cisplatin or any other platinum-containing compound * No serious or uncontrolled infection * No other medical condition or reason that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior immunotherapy Chemotherapy * Prior cisplatin allowed * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radiotherapy Surgery * Not specified Other * Recovered from all prior therapy * No concurrent vitamins, antioxidants, herbal preparations, or supplements * Concurrent single tablet multivitamin allowed * No other concurrent investigational medications

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• Dickson MA, Carvajal RD, Merrill AH Jr, Gonen M, Cane LM, Schwartz GK. A phase I clinical trial of safingol in combination with cisplatin in advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2484-92. doi: 10.1158/1078-0432.CCR-10-2323. Epub 2011 Jan 21.

  PMID: 21257722 RESULT

MeSH Terms

Interventions

Cisplatin; safingol

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gary K. Schwartz, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

• Archie N. Tse, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: March 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: March 22, 2013

Record last verified: 2013-03

Locations

US (1)