Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate, Prednisone, Rituximab, Pegfilgrastim, and Sargramostim as Front-Line Therapy in Treating Patients With Aggressive Non-Hodgkin Lymphoma
Recruitment status was Recruiting
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Purpose
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as pegfilgrastim and sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. Giving combination chemotherapy together with rituximab and biological therapy may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sargramostim when given together with pegfilgrastim, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and rituximab as front-line therapy in treating patients with aggressive non-Hodgkin lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: pegfilgrastim Biological: rituximab Biological: sargramostim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Other: R-CHOP regimen Radiation: external beam radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I-II Study of Dose Dense of PEG-Filgrastim and GM-CSF as Support for Dose Dense CHOP-R Front Line Therapy for Aggressive Non-Hodgkin's Lymphoma |
- Ideal dose of sargramostim administered with dose-dense cyclophosphamide, doxorubicin Hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP), plus fixed-dose of pegfilgrastim [ Designated as safety issue: No ]
- Effectiveness of regimen in inducing very early remissions as measured by the CT-PET scan [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- To identify the ideal dose of the combination of dose-dense cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, prednisone, and rituximab (R-CHOP) front-line therapy with first a fixed-dose of pegfilgrastim and an escalating-dose of sargramostim in patients with aggressive stage I-IV non-Hodgkin lymphoma.
Secondary
- To generate preliminary pilot data as to the effectiveness of this regimen in inducing very early remissions as measured by the CT-PET scan.
OUTLINE: This is a dose-escalation study of sargramostim.
Patients receive rituximab IV on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin Hydrochloride IV over 15 minutes, and vincristine sulfate IV over 15 minutes on day 2 and oral prednisone once daily on days 1-5. Patients also receive pegfilgrastim subcutaneously (SC) on day 3 and sargramostim SC 3 days a week. Treatment repeats every 14 days for up to 6* courses in the absence of unacceptable toxicity.
NOTE: *Patients with stage IA presentation with low beta 2-microglobulin and low LDH are treated with 3 courses of CHOP-R followed by involved-field radiation.
Blood samples are collected periodically for laboratory studies.
After completion of study therapy, patients are followed up for at least 1 month.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive non-Hodgkin lymphoma with the following subtypes:
- Follicular large cell
- Peripheral T-cell
- Diffuse large cell
- Transformed
- Lymphoblastic
- Burkitt and Burkitt-like
- Stage I-IV disease
- Previously untreated disease
- Must have measurable or evaluable disease
- No CNS involvement by lymphoma
PATIENT CHARACTERISTICS:
- Absolute neutrophils ≥ 1,000/mm ^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin < 2 mg/dL
- Creatinine < 2.0 mg/dL or estimated creatinine clearance ≥ 30 cc/min
- No evidence of grade 3 or more neurosensory or neuromotor dysfunction
- No HIV positivity or hepatitis B or C infection
No uncontrolled intercurrent disease, including any of the following:
- Arrhythmias
- Angina pectoris
- Class III-IV congestive heart failure (CHF) (CHF symptoms on less than ordinary exertion or at rest)
- Active infection (fever > 38.2 degrees Celsius unless due to lymphoma)
- Fertile patients must use effective contraception
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations| Puerto Rico | |
| Centro de Cancer del Hospital Auxilio Mutuo | Recruiting |
| San Juan, Puerto Rico, 00936-2712 | |
| Contact: Clinical Trial Coordinator 787-771-7933, ext. 3569 iliboy@auxiliomutuo.com | |
| Study Chair: | Fernando Cabanillas, MD | Auxilio Mutuo Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT01297478 History of Changes |
| Other Study ID Numbers: | CDR0000695270, CCAM-05-02 |
| Study First Received: | February 15, 2011 |
| Last Updated: | February 15, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma stage I grade 3 follicular lymphoma stage III grade 3 follicular lymphoma |
stage IV grade 3 follicular lymphoma peripheral T-cell lymphoma contiguous stage II adult Burkitt lymphoma contiguous stage II adult diffuse large cell lymphoma contiguous stage II adult lymphoblastic lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Doxorubicin Prednisone Vincristine Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 21, 2013