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

Clinical trial: S0423 Pemetrexed Disodium in Treating Patients With Recurrent and Unresectable or Metastatic Chondrosarcoma

Summary: RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
  PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent and unresectable or metastatic chondrosarcoma.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the response rate (confirmed and unconfirmed complete response and partial response) in patients with recurrent and unresectable or metastatic chondrosarcoma treated with pemetrexed disodium.
  Secondary
  -  Determine the toxicity of this drug in these patients.
  -  Correlate, preliminarily, response rates with deletions of methylthioadenosine phosphorylase (MTAP), as analyzed by fluorescence in-situ hybridization (FISH), in patients treated with this drug.
  OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (yes vs no).
  Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity. Beginning 7 days before the first dose of pemetrexed disodium and continuing until 21 days after the completion of pemetrexed disodium, patients receive cyanocobalamin (vitamin B_12) intramuscularly once every 63 days and oral folic acid once daily.
  NOTE: *The duration of course 1 is 28 days; the duration of all subsequent courses is 21 days.
  Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients achieving a confirmed partial response (PR) that is resectable, proceed to surgical resection and then receive 2 additional courses of therapy after recovering from surgery. Patients achieving a confirmed PR that is not resectable continue treatment in the absence of disease progression or unacceptable toxicity.
  After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
  PROJECTED ACCRUAL: A total of 40-75 patients (20-40 in the previously treated stratum and 20-35 in the previously untreated stratum) will be accrued for this study within 20-37.5 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically or cytologically confirmed chondrosarcoma
  -  Histologic grade G2 or G3
  -  Recurrent and unresectable OR metastatic disease
  -  Measurable disease by x-ray, scan, ultrasound, or physical examination
  -  No known CNS metastases
  PATIENT CHARACTERISTICS:
  Age
  -  18 and over
  Performance status
  -  Zubrod 0-2
  Life expectancy
  -  Not specified
  Hematopoietic
  -  Absolute neutrophil count ≥ 1,500/mm^3
  -  Platelet count ≥ 100,000/mm^3
  Hepatic
  -  Bilirubin < 1.5 times upper limit of normal (ULN)
  -  SGOT or SGPT < 2.5 times ULN (5 times ULN if liver metastases are present)
  Renal
  -  Creatinine clearance > 45 mL/min
  Other
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  Able to swallow oral medication
  -  No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  More than 28 days since prior biologic therapy for this malignancy
  Chemotherapy
  -  More than 28 days since prior chemotherapy for this malignancy
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  At least 60 days since prior radiotherapy to the target lesion*
  -  No concurrent radiotherapy NOTE: *Target lesion must have demonstrated disease progression after completion of therapy
  Surgery
  -  At least 21 days since prior surgery and recovered
  Other
  -  More than 28 days since prior investigational drugs for this malignancy
  -  At least 60 days since prior embolization or radiofrequency ablation to the target lesion*
  -  No more than 2 prior treatment regimens for this malignancy
  -  No concurrent antiretroviral therapy for HIV-positive patients NOTE: *Target lesion must have demonstrated disease progression after completion of therapy

Relevance to patient case: not relevant