Chemotherapy Based on Positron Emission Tomography Scan in Treating Patients With Stage I or Stage II Hodgkin Lymphoma
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Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high energy x-rays to kill cancer cells. Giving combination chemotherapy together with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started. Comparing results of diagnostic procedures, such as PET scan, done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This phase II trial is studying how well chemotherapy based on PET scan works in treating patients with stage I or stage II Hodgkin lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: bleomycin sulfate Drug: ABVD regimen Drug: BEACOPP regimen Drug: cyclophosphamide Drug: dacarbazine Drug: doxorubicin hydrochloride Drug: etoposide Drug: prednisone Drug: procarbazine hydrochloride Drug: vinblastine sulfate Drug: vincristine sulfate Other: laboratory biomarker analysis Procedure: computed tomography Radiation: fludeoxyglucose F 18 Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Response-Adapted Chemotherapy Based on Positron Emission Tomography for Non-Bulky Stage I and II Hodgkin Lymphoma |
- Progression-free survival (PFS) at 36 months [ Designated as safety issue: No ]
- PFS after 2 courses of ABVD [ Designated as safety issue: No ]
- Complete response rate [ Designated as safety issue: No ]
- FDG/PET uptake [ Designated as safety issue: No ]
- Volumetric changes on CT scan after courses 2 and 4 of ABVD [ Designated as safety issue: No ]
- Changes in metabolic parameters [ Designated as safety issue: No ]
| Estimated Enrollment: | 149 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | June 2016 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* Hodgkin lymphoma
- Clinical stage IA, IB, IIA, or IIB disease according to the modified Ann Arbor Staging Classification system
- Subclassified according to the WHO modification of the Rye Classification
- "E" extension allowed provided all other criteria have been met NOTE: *Pathology materials must be submitted within 60 days of study registration. Core-needle biopsies are acceptable provided they contain adequate tissue for primary diagnosis and immunophenotyping. Fine-needle aspirates not allowed. If multiple specimens are available, submit the most recent.
- No nodular lymphocyte-predominant Hodgkin lymphoma
- No mediastinal mass > 0.33 maximum intrathoracic diameter by standing postero-anterior chest x-ray or peripheral or retroperitoneal adenopathy > 10 cm in its largest diameter
Measurable disease by physical examination or imaging studies
- Any tumor mass measurable in two dimensions and > 1 cm (or 1.5 cm if 0.5 cm slices are used, as in spiral CT scans) allowed
Lesions that are considered intrinsically non-measurable include:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Lymphangitis cutis/pulmonis
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Lesions that are situated in a previously irradiated area
PATIENT CHARACTERISTICS:
- Performance status 0-2
- ANC ≥ 1,000/μL
- Platelet count ≥ 100,000/μL
- Serum creatinine ≤ 2 mg/dL
- Bilirubin ≤ 2 mg/dL
- AST ≤ 2 times upper limit of normal
- LVEF normal by ECHO or MUGA
- DLCO ≥ 60% with no symptomatic pulmonary disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
Patients with known HIV allowed provided they have CD4 counts ≥ 350/mcL
- Patients must not have multi-drug resistant HIV infections (i.e., concurrent AIDS-defining conditions)
- An HIV test is required for patients with a history of IV drug abuse or any behavior associated with an increased risk of HIVinfection
No "currently active" second malignancy other than nonmelanoma skin cancers
- Patients are not considered to have a "currently active" malignancy provided they have completed therapy and are considered by their physician to be at < 30% risk of relapse
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
No prior chemotherapy or radiotherapy for Hodgkin lymphoma
- 1 course of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) allowed and will be considered the first course
Contacts and Locations
Show 95 Study Locations| Principal Investigator: | David J. Straus, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M. Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT01132807 History of Changes |
| Other Study ID Numbers: | CDR0000672913, CALGB-50604 |
| Study First Received: | May 27, 2010 |
| Last Updated: | February 17, 2013 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I adult Hodgkin lymphoma stage II adult Hodgkin lymphoma adult favorable prognosis Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma |
adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult unfavorable prognosis Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bleomycin Doxorubicin Cyclophosphamide Dacarbazine Etoposide Prednisone Procarbazine |
Vinblastine Vincristine Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013