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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00536601
First received: September 27, 2007
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

RATIONALE: Giving high-dose chemotherapy with or without total-body irradiation before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. It is also given to prepare the patient's bone marrow 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 and radiation therapy.

PURPOSE: This phase II/III clinical trial is studying different high-dose chemotherapy regimens with or without total-body irradiation to compare how well they work when given before autologous stem cell transplant in treating patients with hematologic cancer or solid tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Neuroblastoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: busulfan
Drug: carboplatin
Drug: carmustine
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Drug: thiotepa
Radiation: total-body irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Response rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Impact of prognostic significance of disease-specific standard-, intermediate-, and high-risk groups on prediction of relapse risk post-transplantation [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 174
Study Start Date: June 2006
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT6
Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and undergo total-body irradiation twice daily on days -3 to -1. Patients undergo ASCT on day 0.
Drug: cyclophosphamide
Given IV
Radiation: total-body irradiation
Given on 2 days
Experimental: BuC2iv
Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 for a total of 16 doses and cyclophosphamide IV over 2 hours on days -3 and -2.
Drug: busulfan
Given IV
Drug: cyclophosphamide
Given IV
Experimental: CBV
Patients receive etoposide IV continuously over 34 hours beginning on day -8, cyclophosphamide IV over 2 hours on days -7 to -4, and carmustine IV over 2 hours on day -3.
Drug: carmustine
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Experimental: M200
Patients receive 200 mg/m² of melphalan IV over 30 minutes on day -2.
Drug: melphalan
Given IV
Experimental: M120
Patients receive 120 mg/m² of melphalan IV over 30 minutes on day -2.
Drug: melphalan
Given IV
Experimental: VCp
Patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4. Approximately 4-8 weeks after the first stem cell transplant, patients receive etoposide IV over 2-3 hours and carboplatin IV over 30 minutes on days -6 to -4.
Drug: carboplatin
Given IV
Drug: etoposide
Given IV
Experimental: TtC1500/ECpM
Patients receive thiotepa IV over 2 hours on days -7 to -5 and cyclophosphamide IV over 1-2 hours on days -5 to -2. Approximately 4-8 weeks after the first stem cell transplant, patients receive etoposide IV continuously and carboplatin IV continuously on days -7 to -4 and melphalan IV over 30 minutes on days -7 to -5.
Drug: carboplatin
Given IV
Drug: cyclophosphamide
Given IV
Drug: etoposide
Given IV
Drug: melphalan
Given IV
Drug: thiotepa
Given IV
Experimental: CTtCp
Patients receive cyclophosphamide IV continuously, carboplatin IV continuously, and thiotepa IV continuously on days -7 to -4.
Drug: carmustine
Given IV
Drug: cyclophosphamide
Given IV
Drug: thiotepa
Given IV

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed diagnosis of 1 of the following:

    • Hodgkin lymphoma, meeting the following criteria:

      • Relapsed or refractory disease after ≥ 1 prior standard chemotherapy regimen
      • Must have received 2 prior courses of salvage chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells
    • Non-Hodgkin lymphoma, meeting the following criteria:

      • Low-, intermediate-, or high-grade disease, meeting 1 of the following criteria:

        • Relapsed or refractory disease after ≥ 1 prior standard chemotherapy regimen
        • Small non-cleaved cell or lymphoblastic lymphoma in first complete remission (CR) at high risk for relapse by IPI score
      • Must have received 2 prior courses of salvage chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells
    • Acute myeloid leukemia, meeting the following criteria:

      • Low- or high-risk disease in first or second CR or greater
      • Must have received 2 prior courses of chemotherapy (induction chemotherapy and mobilization chemotherapy) followed by disease-specific restaging prior to mobilization and collection of stem cells
      • Risk of allogeneic stem cell transplantation outweighs the benefits
    • Acute lymphoblastic leukemia, meeting the following criteria:

      • Low- or high-risk disease in first or second CR or greater
      • Must have received 2 prior courses of chemotherapy (induction chemotherapy and mobilization chemotherapy) followed by disease-specific restaging prior to mobilization and collection of stem cells
      • Risk of allogeneic stem cell transplantation outweighs the benefits
    • Multiple myeloma, meeting the following criteria:

      • Low- or high-risk disease in first or greater response (stable disease or better) OR responding disease and now in first progression
      • Must have received 2 prior courses of chemotherapy (≥ 1 of the courses must have been standard induction therapy) followed by disease-specific restaging prior to mobilization and collection of stem cells
    • Other malignant lymphoproliferative disease, including chronic lymphocytic leukemia or Waldenstrom macroglobulinemia, meeting the following criterion:

      • Relapsed or refractory disease after first-line chemotherapy
    • Amyloidosis, meeting the following criteria:

      • Primary or previously treated disease
      • Prior induction chemotherapy is not required
    • Patients with malignancies who would be treated with an autologous stem cell transplant but have a syngeneic donor. A syngeneic donor would be considered to have the same risk as an autologous stem cell transplant patient.
    • Solid tumors, including any of the following:

      • Testicular cancer, meeting the following criteria:

        • Relapsed disease or primary progressive disease that responded to salvage therapy

          • Must have received 2 prior courses of salvage chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells
      • Neuroblastoma, meeting the following criteria:

= 30 years of age or under

  • Relapsed disease OR newly diagnosed advanced disease

    • Must have received 2 prior courses of chemotherapy (induction chemotherapy and mobilization chemotherapy) followed by disease-specific restaging prior to mobilization and collection of stem cells

      • Small round blue cell tumor, meeting the following criteria:

= 30 years of age or under

  • Relapsed disease OR newly diagnosed advanced disease
  • Must have received either prior standard chemotherapy or surgical intervention

    • Other solid tumor, meeting the following criteria:
  • Recurrent disease following conventional therapy OR at high risk for relapse
  • Must have received 2 prior courses of chemotherapy followed by disease-specific restaging prior to mobilization and collection of stem cells
  • Demonstrates chemosensitivity

    • Allogeneic stem cell transplantation (SCT) is not possible, or is not desirable (e.g., over 65 years of age; no compatible donor available; and estimated risk of graft-versus-host disease complications are greater than risk of recurrence after autologous SCT)
    • Adequate bone marrow or peripheral blood stem cell dose obtained

      • Total CD34+ peripheral blood stem cell dose ≥ 2 x 10^6/kg, or if unable to collect this dose, total nucleated cell bone marrow dose ≥ 1 x 10^8/kg
      • Bone marrow may be used in conjunction with blood progenitor cells NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 70-100% or PS 0-2

    • Patients with amyloidosis or multiple myeloma with decreased Karnofsky PS due to disease are eligible
  • Life expectancy > 2 months
  • ANC > 1,500/mm³
  • Platelet count > 75,000/mm³
  • Bilirubin < 3 times upper limit of normal (ULN)
  • Alkaline phosphatase < 3 times ULN
  • SGOT < 3 times ULN
  • Creatinine clearance ≥ 50 mL/min (requirement waived in selected multiple myeloma and amyloidosis patients due to renal compromise characteristic of the disease)

    • Glomerular filtration rate by renal scan required for patients with neuroblastoma
  • HIV I and HIV II antibody negative
  • DLCO or DLVA ≥ 50% of predicted (DLCO to be corrected for hemoglobin and/or alveolar ventilation)
  • Cardiac ventricular ejection fraction ≥ 50% by radionuclide ventriculogram or echocardiogram
  • No uncontrolled or severe cardiovascular disease, including any of the following:

    • Myocardial infarction within the past 6 months
    • Congestive heart failure
    • Symptomatic angina
    • Life-threatening arrhythmia
    • Hypertension
  • No active bacterial, viral, or fungal infection

    • Patients with positive CMV IgM and/or positive hepatitis serologies demonstrating infection, or any other active infection, will require an Infectious Disease consult and subsequent clearance
  • No active peptic ulcer disease
  • No uncontrolled diabetes mellitus
  • No other serious organ dysfunction unless it is caused by the underlying disease
  • No serious medical or psychiatric illness
  • No psychiatric condition that would prevent delivery of care (psychology clearance is necessary)
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No radiotherapy within 3 weeks prior to stem cell harvest
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536601

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Philip L. McCarthy, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00536601     History of Changes
Other Study ID Numbers: CDR0000565267, RPCI-I-72806
Study First Received: September 27, 2007
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
unspecified adult solid tumor, protocol specific
unspecified childhood solid tumor, protocol specific
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
disseminated neuroblastoma
localized unresectable neuroblastoma
recurrent neuroblastoma
regional neuroblastoma
stage 4S neuroblastoma
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
primary systemic amyloidosis
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
recurrent childhood grade III lymphomatoid granulomatosis
recurrent childhood large cell lymphoma
recurrent childhood lymphoblastic lymphoma
recurrent childhood small noncleaved cell lymphoma
stage I childhood lymphoblastic lymphoma
stage II childhood lymphoblastic lymphoma
stage III childhood lymphoblastic lymphoma
stage IV childhood lymphoblastic lymphoma
stage I childhood small noncleaved cell lymphoma
stage II childhood small noncleaved cell lymphoma

Additional relevant MeSH terms:
Neoplasms
Leukemia
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Nervous System Neoplasms
Neuroblastoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Central Nervous System Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Neoplasms by Site
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on May 16, 2013