High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors

NCT00060255 | Completed Phase 2 DMC

• 2 other identifiers: CDR0000301587RPCI-DS-9115
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.

Conditions

Breast Cancer; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

stage IV breast cancer; male breast cancer; recurrent malignant testicular germ cell tumor; Waldenstrom macroglobulinemia; childhood acute lymphoblastic leukemia in remission; adult acute lymphoblastic leukemia in remission; recurrent adult acute myeloid leukemia; adult acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; childhood acute myeloid leukemia in remission; chronic phase chronic myelogenous leukemia; accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; refractory chronic lymphocytic leukemia; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; unspecified adult solid tumor, protocol specific; unspecified childhood solid tumor, protocol specific; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; recurrent breast cancer; primary systemic amyloidosis; refractory multiple myeloma; childhood chronic myelogenous leukemia; atypical chronic myeloid leukemia; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)

Outcome Measures

Primary Outcomes (7)

• Morbidity

  +day 100

• Mortality

  +day 100, +day 360

• Overall outcome

  every 6 months until death

• Response rate

  +day 100, +day 360

• Toxicity

  +day100, +day 360

• Disease-free survival

  up to 15years

• Overall survival

  every 6 months until death

Interventions

busulfan DRUG

iv

carboplatin DRUG

iv

carmustine DRUG

iv

cyclophosphamide DRUG

iv

etoposide DRUG

iv

melphalan DRUG

oral

thiotepa DRUG

iv

autologous bone marrow transplantation PROCEDURE

iv

bone marrow ablation with stem cell support PROCEDURE

iv

peripheral blood stem cell transplantation PROCEDURE

iv

radiation therapy RADIATION

body x-ray

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed hematologic or solid tumor malignancy, including any of the following: * Acute myeloid leukemia * First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission * Not eligible for protocol CLB-9620 or CLB-9621 * Acute lymphoblastic leukemia * First complete remission without appropriate allogeneic donor * Chronic myelogenous leukemia * Chronic, accelerated, or blast phase * Lymphoproliferative diseases\* * Chronic lymphocytic leukemia * Multiple myeloma * Waldenstrom's macroglobulinemia * Low-grade non-Hodgkin's lymphoma (NHL) NOTE: \*Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently * Amyloidosis * Primary or previously treated disease * NHL (intermediate- and high-grade) * Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen * First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse * CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L * Hodgkin's lymphoma * Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen * Solid tumors * High-risk and metastatic breast cancer * Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy * Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity * Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged) * Allogeneic marrow transplantation not possible or not desirable for any of the following reasons: * Over 60 years of age * No compatible donor identified * Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation * Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens * Hormone receptor status: * Not specified 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: Age * 4 and over (patients 60 years of age and over are not eligible for TBI) Sex * Male or female Menopausal status * Not specified Performance status * Karnofsky 70-100% Life expectancy * More than 2 months Hematopoietic * WBC greater than 3,000/mm\^3\* * Polymorphonuclear leukocyte count greater than 1,500/mm\^3\* * Platelet count greater than 75,000/mm\^3\* * Marrow cellularity greater than 20%\* * No marrow fibrosis\* NOTE: \*Before marrow storage Hepatic * Bilirubin less than 3 times normal * Alkaline phosphatase less than 3 times normal * AST less than 3 times normal * Hepatitis status known Renal * Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma) Cardiovascular * Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram * No myocardial infarction within the past 6 months * No congestive heart failure * No symptomatic angina * No life-threatening arrhythmia or hypertension Pulmonary * DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation) Other * Not pregnant * HIV negative * Cytomegalovirus status known * No active bacterial, viral, or fungal infection * No active peptic ulcer disease * No uncontrolled diabetes mellitus * No serious organ dysfunction unless it is caused by the underlying disease * No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics Chemotherapy * See Disease Characteristics * No prior cumulative nitrosourea dose greater than 600 mg/m\^2 * No prior cumulative bleomycin dose greater than 150 units/m\^2 * No prior cumulative doxorubicin dose greater than 450 mg/m\^2 * No prior cumulative daunorubicin dose greater than 600 mg/m\^2 * Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m\^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * More than 3 weeks since prior radiotherapy (before blood stem cell harvest) * Prior cumulative doses of radiotherapy must not exceed the following: * Spine/spinal cord: 4,000 cGy * Mediastinum: 4,000 cGy * Heart: 4,000 cGy * Kidney (whole): 1,500 cGy * Small bowel: 4,000 cGy * Brain: 4,000 cGy * Liver (whole): 2,000 cGy * Lungs (whole): 1,500 cGy * Bone: 5,000 cGy Surgery * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Leukemia; Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Testicular Germ Cell Tumor; Breast Neoplasms, Male; Testicular Neoplasms; Waldenstrom Macroglobulinemia; Leukemia, Myeloid, Acute; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Blast Crisis; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Burkitt Lymphoma; Hodgkin Disease; Lymphoma, Large-Cell, Immunoblastic; Dendritic Cell Sarcoma, Interdigitating; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Recurrence; Immunoglobulin Light-chain Amyloidosis; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative; Lymphoma, B-Cell, Marginal Zone; Congenital Abnormalities

Interventions

Busulfan; Carboplatin; Carmustine; Cyclophosphamide; Etoposide; Melphalan; Thiotepa; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoma, B-Cell; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Histiocytic Disorders, Malignant; Histiocytosis; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Myelodysplastic-Myeloproliferative Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Coordination Complexes; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Philip L. McCarthy, MD

  Roswell Park Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: December 1, 1991
• Primary Completion: August 1, 2006
• Study Completion: February 1, 2013
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

US (1)