Phase 2
Completed N=93
Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma
Source: ClinicalTrials.gov NCT00082888 ↗Enrolled (actual)
93
Serious AEs
55.4%
Results posted
Dec 2011
Primary outcomePrimary: Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment — 0.17; 0.07; 0.31 Proportion of participants
Summary
This phase II trial studies how well tipifarnib works in treating patients with relapsed or refractory non-Hodgkin's lymphoma. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Tipifarnib may be an effective treatment for non-Hodgkin's lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment |
0.17; 0.07; 0.31 | — |
| SECONDARY Overall Survival |
6.4; 20.6; 19.7 | — |
| SECONDARY Time to Progression |
2.8; 5.2; 3.2 | — |
| SECONDARY Duration of Response |
11.3; 2; 7.5 | — |
| SECONDARY Number of Patients Who Experienced Grade 3 or 4 Toxicities |
32; 8; 24 | — |
Eligibility Criteria
Inclusion Criteria
- Biopsy-proven relapsed or refractory lymphomas; previous biopsies = = 2 cm or tumor cells in the blood >= 5 x10^9/L
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- Absolute neutrophil count >=1000/mm^3
- Platelet count >= 75,000
- Hemoglobin >= 9 g/dL
- Total bilirubin = 2 x ULN direct bilirubin is required and should be = = 3 months
- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
- Capable of swallowing intact study medication tablets
- Capable of following directions regarding taking study medication, or has a daily caregiver who will be responsible for administering study medication
Exclusion Criteria
- Any of the following as this regimen may be harmful to a developing fetus or nursing child:
- Pregnant women
- Breastfeeding women
- Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
- NOTE: The effects of R115777 on the developing human fetus at the recommended therapeutic dose are unknown
- Life-threatening illness (unrelated to tumor)
- Ongoing radiation therapy or radiation therapy = = grade 3
- Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives
- Presence of central nervous system (CNS) lymphoma
- Other active malignancies
- Once a patient begins FTI (tipifarnib) treatment, the addition of other cancer treatment will confound the assessment of efficacy and therefore is not allowed; this restriction precludes the addition of cytotoxic, immunologic agents, radiotherapy, or an increase in corticosteroid dose while the patient is in the treatment phase of this protocol
- Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required but should be done if clinically indicated; HIV patients are excluded because of concerns regarding excess risk of complications of immunosuppressive therapy regimens
- Known allergy to imidazole drugs such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, sulconazole, tioconazole, or terconazole
Data sourced from ClinicalTrials.gov (NCT00082888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.