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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CCF-5386 | Other Identifier | Cleveland Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.
PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.
OBJECTIVES:
Primary
OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk [primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poor Risk | Experimental | Primary progressive, recurrent, or resistant relapse patients |
|
| Good Risk | Experimental | First recurrence patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| filgrastim | Biological | 480 mcg beginning day +5 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions. | one year after second transplant |
| Response Rate | Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions. | One year after second transplant |
| Number of Patients That Experience Pulmonary Toxicity | Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs. | One year after second transplant |
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DISEASE CHARACTERISTICS:
Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:
No clonal abnormalities in marrow collection
Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection
Must have adequate sections of original diagnostic specimen available for review
No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5 years)
No CNS involvement
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Brian J. Bolwell, MD | Cleveland Clinic Taussig Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
Only Poor Risk Patients were enrolled.
Patients recruited from medical clinic from August 2002 thru October 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Poor Risk Patients | Poor Risk (primary progressive, recurrent, or resistant relapse) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| busulfan |
| Drug |
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses |
|
| cyclophosphamide | Drug | 60 mg/kg IV over 2 hours x 2 days |
|
| etoposide | Drug | 60 mg/kg, IV |
|
| melphalan | Drug | 150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes. |
|
| autologous-autologous tandem hematopoietic stem cell transplantation | Procedure | autologous-autologous tandem hematopoietic stem cell transplantation |
|
| radiation therapy | Radiation | radiation therapy |
|
| Cycle 1: 1st Regimen/Transplant |
|
| Cycle 2: 2nd Regimen/Transplant |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Poor Risk Patients | Poor Risk (primary progressive, recurrent, or resistant relapse) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression-free Survival | Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions. | Analysis is per protocol, so includes patients who received both transplants | Posted | Number | participants | one year after second transplant |
|
|
| ||||||||||||||||||||||||||
| Primary | Response Rate | Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions. | Analysis is per protocol, so includes patients who received both transplants | Posted | Number | participants | One year after second transplant |
|
| |||||||||||||||||||||||||||
| Primary | Number of Patients That Experience Pulmonary Toxicity | Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs. | Analysis is per protocol, so includes patients who received treatment | Posted | Number | participants | One year after second transplant |
|
|
Adverse events were collected from the time the patient went on study to off study, approximately a 6 month time frame per patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Poor Risk Patients | Poor Risk (primary progressive, recurrent, or resistant relapse) | 1 | 37 | 23 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Cardiac Dysfuntion | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Infections | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
| |
| Respiratory Dysfunction | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Acute Renal Failure | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
| |
| Gastrointestinal-other | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Bowell, MD | Case Comprehensive Cancer Center | 216-444-6922 | bolwelb@ccf.org |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069585 | Filgrastim |
| D002066 | Busulfan |
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008558 | Melphalan |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D013812 | Therapeutics |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Title | Denominators | Categories |
|---|
|