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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma  CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
For Condition: recurrent mantle cell lymphoma
Status: Recruiting
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of CCI-779 in treating patients who have mantle cell non-Hodgkin's lymphoma.
Details: OBJECTIVES: - Determine the objective responses in patients with previously treated mantle cell non-Hodgkin's lymphoma treated with CCI-779. - Determine the toxic effects of this drug in these patients. - Determine whether this drug inhibits cell proliferation pathways in these patients. OUTLINE: Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with stable disease receive a maximum of 6 courses. Patients with partial response receive a maximum of 12 courses. Patients with complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually for 2 years. PROJECTED ACCRUAL: A maximum of 35 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mantle cell non-Hodgkin's lymphoma (MCL) - Relapsed, refractory, or stable disease after prior chemotherapy, radiotherapy, or immunotherapy - Unidimensionally measurable lymph node or lesion - At least 2.0 cm by CT scan or MRI OR at least 1.5 cm by physical exam - One of the following measurement parameters may be used: - Splenic enlargement may be used as a measurement parameter if spleen is palpable at least 3.0 cm across left costal margin - Malignant lymphocytosis may be used as a measurement parameter if absolute lymphocyte count is at least 5,000/mm^3 - No known CNS involvement (parenchymal mass or leptomeningeal involvement) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR - Direct bilirubin no greater than 1.5 times ULN - AST no greater than 3 times ULN (5 times ULN if liver metastases are present) Renal: - Creatinine no greater than 2 times ULN Cardiovascular: - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - Cholesterol no greater than 350 mg/dL - Triglycerides no greater than 400 mg/dL - HIV negative - No other active malignancy requiring treatment or that would preclude study participation - No other concurrent uncontrolled illness - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Prior high-dose therapy with stem cell transplantation allowed - At least 7 days since prior immunotherapy or other non-myelosuppressive biologic response modifiers Chemotherapy: - See Disease Characteristics - See Biologic therapy - At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy for MCL Endocrine therapy: - Concurrent corticosteroids for adrenal insufficiency allowed Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy for MCL Surgery: - Not specified Other: - Any number of prior treatments allowed - No other concurrent investigational or commercial agents for MCL - No concurrent drugs that induce cytochrome p450 (e.g., carbamazepine, phenobarbital, phenytoin, ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide) - No concurrent immunosuppressive therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasWitzig, Study Chair, Mayo Clinic Cancer Center
Medcenter One Health System *Recruiting*
Bismark, North Dakota, 58501-5505
United States
Recruiting Edward Wos 701-323-5741
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
MBCCOP - Gulf Coast *Recruiting*
Mobile, Alabama, 36607
United States
Recruiting Paul Schwarzenberger 251-544-1013
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Mayo Clinic *Recruiting*
Jacksonville, Florida, 32224
United States
Recruiting Edith Perez 904-953-0118
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Siouxland Hematology-Oncology *Recruiting*
Sioux City, Iowa, 51101-1733
United States
Recruiting Donald Wender 712-252-0088
CentraCare Health Plaza *Recruiting*
St. Cloud, Minnesota, 56303
United States
Recruiting Harold Windschitl 320-229-5199
Altru Cancer Center *Recruiting*
Grand Forks, North Dakota, 58201
United States
Recruiting Todor Dentchev 701-780-6363
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Daniel Nikcevich 218-786-3625
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Dayton *Recruiting*
Dayton, Ohio, 45429
United States
Recruiting Howard Gross 937-395-8678
CCOP - Upstate Carolina *Recruiting*
Spartanburg, South Carolina, 29303
United States
Recruiting James Bearden 864-560-7050
Rapid City Regional Hospital *Recruiting*
Rapid City, South Dakota, 57709
United States
Recruiting Larry Ebbert 605-341-8704
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Witzig 507-284-2511
Additional Information:
Study ID Numbers: CDR0000069269; NCCTG-N0186
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033267
Other Recurrent Mantle Cell Lymphoma Studies:
1. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
2. Rituximab With or Without Interleukin-12 in Treating Patients With Non-Hodgkin's Lymphoma
3. Combination Chemotherapy and Radiation Therapy Plus Bone Marrow Transplantation in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
4. Monoclonal Antibody Therapy in Treating Patients With Lymphoma, Colon Cancer, or Prostate Cancer That Has Not Responded to Vaccine Therapy
5. Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell Lymphoma
Related Studies:
Other recurrent mantle cell lymphoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
CCI-779 in Treating Patients With Mantle Cell Non-Hodgkin's Lymphoma
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