Trial Information

Summary: Study of tandem high dose chemotherapy and autologous blood stem cell transplantation for lymphoma

The primary goal of this study is to evaluate high dose chemotherapy followed by autologous peripheral blood stem cell transplantation (PBSCT) for the treatment of lymphoma. The protocol will include two autograft procedures performed in sequence, each using preparative regimens with relatively high activity in the treatment of lymphoma: mitoxantrone and melphalan for the first procedure and a combination of etoposide, thiotepa, and carboplatin for the second.

Patients with advanced stage lymphoma (Hodgkin's disease and non-Hodgkin's lymphoma) are treated with chemotherapy. Those who fail to respond to chemotherapy have a dismal prognosis. These patients are generally referred for more radical treatment consisting of high dose chemotherapy and autologous stem cell transplantation. It is possible that the low success rate of autografting for poor risk lymphoma might be improved by using new combinations of drugs for pre-transplant conditioning. Tandem or sequential autografting might further augment tumor responsiveness. We wish to introduce a program of tandem high dose therapy employing melphalan and mitroxantrone prior to the first autograft and etoposide, thiotepa and carboplantin for the second. Mitoxantrone, melphalan, etoposide, thiotepa, and carboplatin all have significant activity in the treatment of lymphoma.

Eligibility:

• Patients have histologically confirmed Hodgkin's disease or non-Hodgkin's lymphoma.
• Patients experienced one of the following:
  • Disease non-responding while receiving multi-agent chemotherapy given at conventional doses (e.g., MOPP, ABVD or equivalent regimen for HD; CHOP or equivalent regimen of NHL).
  • Non-Hodgkin's lymphoma in which high risk features are present at diagnosis, such as: serum LDH > 300 U/L, extranodal disease, a tumor mass > 6 cm in diameter, or mantle cell, immunoblastic, lymphblastic, or Burkitt's histology.
  • Relapse of NHL at any time after achieving CR.
  • Relapse of Hodgkin's disease <12 mos after completion of first line chemotherapy or after any second or subsequent relapse.
• Patient does not have any medical or psychiatric illness preventing informed consent or intensive treatment
• Has not received previous mantle radiotherapy for Hodgekin's disease.

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Trial listings updated: June 1, 2008 at 5:43:10 AM