Patient case: 58-year-old male with gastrointestinal stromal tumor; genetic feature: KIT (exon 9 502_503 duplication)

Clinical trial: Combination Chemotherapy in Treating Patients With Previously Untreated Advanced Hodgkin's Lymphoma

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have advanced Hodgkin's lymphoma.
  PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating patients who have advanced Hodgkin's lymphoma.

Detailed description: OBJECTIVES:
  -  Compare relapse-free and overall survival of patients with previously untreated advanced Hodgkin's lymphoma treated with bleomycin, doxorubicin, etoposide, mechlorethamine, vinblastine, vincristine, and prednisone (Stanford V) vs doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
  -  Compare the toxicity of these regimens in these patients.
  OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
  -  Arm I (Stanford V): Patients receive mechlorethamine on weeks 1, 5, and 9; vinblastine and doxorubicin on weeks 1, 3, 5, 7, 9, and 11; etoposide IV over 30-45 minutes for 2 consecutive days on weeks 3, 7, and 11; and vincristine and bleomycin on weeks 2, 4, 6, 8, 10, and 12. Patients also receive oral prednisone every other day on days 1-63 followed by a taper on days 64-84. Treatment continues for 12 weeks.
  -  Arm II (ABVD): Patients receive doxorubicin, bleomycin, vinblastine, and dacarbazine on days 1 and 15. Treatment repeats every 28 days for 6-8 courses.
  All patients achieving a complete remission or partial remission after chemotherapy undergo involved field radiotherapy if they had initial bulky mediastinal disease, initial nodal masses at least 5 cm in diameter, or initial splenic disease.
  Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
  Peer Reviewed and Funded or Endorsed by Cancer Research UK
  PROJECTED ACCRUAL: Approximately 700-850 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed Hodgkin's lymphoma (any sub-type)
  -  Stage IB, IIB, IIIA, IIIB, or IV OR
  -  Stage IA or IIA with locally extensive disease (e.g., bulky mediastinal disease (e.g., greater than 0.33 of the maximum transthoracic diameter on routine chest X-ray or at least 2 extranodal sites of disease))
  PATIENT CHARACTERISTICS:
  Age:
  -  18 to 60
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Complete blood count normal unless directly due to Hodgkin's lymphoma
  Hepatic:
  -  Hepatic function normal unless directly due to Hodgkin's lymphoma
  Renal:
  -  Renal function normal unless directly due to Hodgkin's lymphoma
  Cardiovascular:
  -  No pre-existing cardiac disease
  Pulmonary:
  -  No pre-existing pulmonary disease
  Other:
  -  Not pregnant
  -  Fertile patients must use effective contraception during and for six months after study
  -  HIV negative
  -  No other prior malignancy except basal cell or squamous cell skin cancer
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  Not specified
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other:
  -  No prior therapy for Hodgkin's lymphoma

Relevance to patient case: not relevant