|Phase II||Treatment||Closed||over 15||NCI||SWOG-9501|
I. Estimate the 2-year progression-free survival of adult patients with previously untreated low-grade, stage III/IV non-Hodgkin's lymphoma treated with fludarabine/mitoxantrone. II. Evaluate the toxicity of fludarabine/mitoxantrone in these patients.
Biopsy-proven low-grade non-Hodgkin's lymphoma Working Formulation A-C Original diagnostic sections required for SWOG pathology review Biopsies must be adequate to determine architectural pattern No bone marrow biopsy or needle aspirate/biopsy Previously untreated stage III/IV (Ann Arbor) No CNS involvement No prior lymphoma or Hodgkin's disease Disease bidimensionally measurable, i.e.: Plain x-ray with 1 diameter 0.5 cm or greater (bone lesions not included) CT, MRI, other imaging scan with both diameters greater than the distance between cuts Palpable lesion with both diameters 2 cm or greater Concurrent registration on protocols SWOG-8947 (serum study) and SWOG-8819 (tissue study) encouraged
No prior therapy
Age: Over 15 Performance status: SWOG 0-2 Hepatic: Bilirubin no greater than 2 times normal Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No severe coronary artery disease No cardiomyopathy No congestive heart failure No arrhythmia Left ventricular ejection fraction normal by ECHO or MUGA if history questionable Other: No known AIDS syndrome or HIV-associated complex No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated in situ cervical cancer No pregnant or nursing women Effective contraception required of fertile patients
80 patients will be entered over 10-12 months.
2-Drug Combination Chemotherapy. FN: Fludarabine, FAMP, NSC-312887; Mitoxantrone, DHAD, NSC-301739.Published Results
Velasquez WS, Lew D, Grogan TM, et al.: Combination of fludarabine and mitoxantrone in untreated stages III and IV low-grade lymphoma: S9501. J Clin Oncol 21 (10): 1996-2003, 2003.[PUBMED Abstract]
Velasquez W, Lew D, Miller T, et al.: Phase II trial of a combination of fludarabine and mitoxantrone (FN) in untreated advanced low grade lymphoma: an effective, well tolerated therapy. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A27, 9a, 1999.
Trial Lead Organizations
Southwest Oncology Group
|William S. Velasquez, MD, FACP, Protocol chair|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.