Patient case: 26-year-old female with chondrosarcoma; genetic feature: IDH1

Clinical trial: S-3304 in Treating Patients With Advanced Solid Tumors

Summary: RATIONALE: S-3304 may stop or slow the growth of solid tumors by stopping blood flow to the tumor.
  PURPOSE: Phase I trial to study the effectiveness of S-3304 in treating patients who have solid tumors.

Detailed description: OBJECTIVES:
  -  Determine the maximum tolerated dose and safety profile of S-3304 in patients with advanced solid tumors.
  -  Determine the pharmacokinetic profile of this drug in these patients.
  -  Estimate the starting dose of this drug for subsequent phase II efficacy studies.
  OUTLINE: This is a dose-escalation, multicenter study.
  Patients receive oral S-3304 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
  Cohorts of 6-8 patients receive escalating doses of S-3304 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 3 of 8 patients experience dose-limiting toxicity.
  Patients are followed at 30 days.
  PROJECTED ACCRUAL: A total of 6-28 patients will be accrued for this study within 1 year.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed solid tumor that failed to respond or relapsed after prior therapy or for which no standard therapy exists
  -  Biopsy-accessible lesion
  -  No brain metastasis unless clinically stable and off therapy
  PATIENT CHARACTERISTICS:
  Age:
  -  18 and over
  Performance status:
  -  ECOG 0-2
  Life expectancy:
  -  More than 6 weeks
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,500/mm^3
  -  Platelet count at least 100,000/mm^3
  -  Hemoglobin at least 9.0 g/dL
  Hepatic:
  -  Bilirubin no greater than 2 times upper limit of normal (ULN)
  -  Transaminases less than 2.5 times ULN
  Renal:
  -  Creatinine less than 2.0 mg/dL
  Other:
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception during and for at least 30 days after study
  -  Able to tolerate oral medication
  -  HIV negative
  -  No AIDS
  -  No serious underlying gastrointestinal disorders (e.g., recurrent vomiting or inflammatory bowel disease)
  -  No other serious concurrent illness
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  At least 4 weeks since prior immunotherapy
  -  Concurrent stable doses of epoetin alfa are allowed during the second and subsequent courses
  -  No other concurrent immunotherapy
  Chemotherapy:
  -  At least 4 weeks since prior chemotherapy
  -  No concurrent chemotherapy
  Endocrine therapy:
  -  At least 4 weeks since prior hormonal therapy
  -  Concurrent stable doses of steroids for prostate cancer are allowed during the second and subsequent courses
  -  No concurrent hormonal therapy
  Radiotherapy:
  -  At least 4 weeks since prior radiotherapy
  -  No concurrent radiotherapy
  Surgery:
  -  No prior significant gastric resection
  Other:
  -  Recovered from prior therapy
  -  At least 4 weeks since other prior investigational antitumor drugs
  -  No other concurrent investigational antitumor drugs
  -  Concurrent stable doses of bisphosphonates, cyclo-oxygenase-2 inhibitors, and non-steroidal anti-inflammatory drugs are allowed during the second and subsequent study courses

Relevance to patient case: not relevant