Combination Chemotherapy With or Without Dexrazoxane in Treating Children With Hodgkin's Disease
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00005578 |
|
Recruitment Status :
Completed
First Posted : May 26, 2004
Last Update Posted : July 24, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without dexrazoxane in treating children who have Hodgkin's disease.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Toxicity Lymphoma | Biological: bleomycin sulfate Biological: filgrastim Drug: cyclophosphamide Drug: dexrazoxane hydrochloride Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy | Phase 3 |
OBJECTIVES: I. Determine the efficacy of doxorubicin, bleomycin, vincristine, etoposide, prednisone and cyclophosphamide (DBVE-PC) with filgrastim (G-CSF) followed by consolidative radiotherapy in children with advanced stage Hodgkin's disease. II. Tailor therapy based on rapidity of response in order to minimize cumulative drug dosages. III. Compare the efficacy of dexrazoxane in reducing pulmonary and cardiac toxicity of DBVE-based therapy without compromising response.
OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin and etoposide on days 0 and 1, bleomycin and vincristine on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs. Patients assigned to arm II receive dexrazoxane on days 0, 1, and 7 in addition to therapy as in arm I. Patients who exhibit a complete remission (CR) or provisional CR then receive radiotherapy to the regional field 5 days a week for 2.8 weeks. If the disease is not responsive, 2 more courses of chemotherapy are given. Patients whose disease remains nonresponsive or progresses go off the study. Radiotherapy may follow for others. Patients are followed every 3 months for the first year, every 4 months for the second year, every 6 months for the third year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 277 patients will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 219 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single |
| Primary Purpose: | Treatment |
| Official Title: | Advanced Stage Hodgkins Disease - A Pediatric Oncology Group Phase III Study |
| Study Start Date : | March 1997 |
| Actual Primary Completion Date : | October 2004 |
| Actual Study Completion Date : | June 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm 1
Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Patients assigned to arm I receive only these drugs.
|
Biological: bleomycin sulfate
Other Names:
Biological: filgrastim Other Names:
Drug: cyclophosphamide Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: etoposide Other Names:
Drug: prednisone Other Names:
Drug: vincristine sulfate Other Names:
Radiation: radiation therapy |
|
Experimental: Arm 2
Patients are randomized to one of two treatment arms. All patients receive 3 courses of chemotherapy consisting of doxorubicin hydrochloride and etoposide on days 0 and 1, bleomycin sulfate and vincristine sulfate on days 0 and 7, cyclophosphamide on day 0, and prednisone on days 0-6. Filgrastim (G-CSF) is administered on days 5-6 and 8-19. Each course is 21 days in length. Dexrazoxane hydrochloride on days 0, 1, and 7
|
Biological: bleomycin sulfate
Other Names:
Biological: filgrastim Other Names:
Drug: cyclophosphamide Other Names:
Drug: dexrazoxane hydrochloride Other Names:
Drug: doxorubicin hydrochloride Other Names:
Drug: etoposide Other Names:
Drug: prednisone Other Names:
Drug: vincristine sulfate Other Names:
Radiation: radiation therapy |
- Diffusing capacity of the lungs for carbon monoxide (DLCO) [ Time Frame: One year post therapy ]The Wilcoxon test will be used to evaluate whether DLCO values differ between the two arms.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | up to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease of the following stages: Stages IIB, IIIB or IV
PATIENT CHARACTERISTICS: Age: 21 or under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin less than 2 times upper normal limit Renal: Not specified Other: Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy Chemotherapy: No prior chemotherapy Endocrine therapy: Less than one week of steroids for management of airway complications Radiotherapy: No prior radiotherapy except emergency radiation to the mediastinum Surgery: Not specified
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005578
Show 63 Study Locations
| Study Chair: | Cindy Schwartz, MD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Publications of Results:
Other Publications:
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00005578 History of Changes |
| Other Study ID Numbers: |
9425 COG-9425 ( Other Identifier: Children's Oncology Group ) CDR0000065359 ( Other Identifier: Clinical Trials.gov ) P9425 ( Other Identifier: Pediatric Oncology Group ) |
| First Posted: | May 26, 2004 Key Record Dates |
| Last Update Posted: | July 24, 2014 |
| Last Verified: | July 2014 |
Keywords provided by Children's Oncology Group:
|
stage II childhood Hodgkin lymphoma stage I childhood Hodgkin lymphoma stage III childhood Hodgkin lymphoma stage IV childhood Hodgkin lymphoma cardiac toxicity |
Additional relevant MeSH terms:
|
Lymphoma Hodgkin Disease Cardiotoxicity Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Pathologic Processes Drug-Related Side Effects and Adverse Reactions Chemically-Induced Disorders Radiation Injuries Wounds and Injuries Cyclophosphamide |
Doxorubicin Liposomal doxorubicin Prednisone Etoposide Etoposide phosphate Vincristine Bleomycin Dexrazoxane Razoxane Lenograstim Sargramostim Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |