Clinical Trial: High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors

Brief Summary: This pilot trial studies different high-dose chemotherapy regimens with or without total-body irradiation (TBI) to compare how well they work when given before autologous stem cell transplant (ASCT) in treating patients with hematologic cancer or solid tumors. Giving high-dose chemotherapy with or without TBI before ASCT stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood or bone marrow and stored. More chemotherapy may be given to prepare for the stem cell transplant. The stem cells are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Estimate the progression free survival (PFS) distribution for Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) for each disease-specific high dose therapy regimen.

SECONDARY OBJECTIVES:

I. Estimate the PFS distribution for amyloidosis, acute leukemia and selected solid tumors for each disease-specific high dose therapy regimen.

II. Explore the role of risk factors in the outcome of all treated patients. III. Examine the high dose therapy regimen-related toxicity (RRT) and overall survival after bone marrow transplant (BMT).

OUTLINE:

Patients are assigned to conditioning regimens based on disease, age, and co-morbidities.


Sponsor: Roswell Park Cancer Institute

Current Primary Outcome: Progression-free survival distribution of patients with HL, NHL, and MM for each disease-specific high-dose therapy regimen [ Time Frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years ]

Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed based on Greenwood's formula for the variance of the survival function.


Original Primary Outcome:

  • Progression-free survival
  • Efficacy
  • Toxicity
  • Response rates
  • Overall survival
  • Impact of prognostic significance of disease-specific standard-, intermediate-, and high-risk groups on prediction of relapse risk post-transplantation


Current Secondary Outcome:

  • Progression-free survival distribution of patients with amyloidosis, acute leukemia, and selected solid tumors for each disease-specific high-dose therapy regimen [ Time Frame: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years ]
    Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed based on Greenwood's formula for the variance of the survival function.
  • Regimen-related toxicity [ Time Frame: At 100 days ]
    Toxicities will be reported using descriptive statistics.
  • Response rate [ Time Frame: At 100 days ]
    Response rates will be reported using descriptive statistics.
  • Overall survival [ Time Frame: Up to 12 years ]
    Assessed using the product-limit based Kaplan Meier method.


Original Secondary Outcome:

Information By: Roswell Park Cancer Institute

Dates:
Date Received: September 27, 2007
Date Started: June 29, 2006
Date Completion: April 18, 2018
Last Updated: March 30, 2017
Last Verified: March 2017