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Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma

Phase 2
18 Years
Open (Enrolling)
Anaplastic Large Cell Lymphoma, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Peripheral T-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma

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Trial Information

Phase II Evaluation of FTI (R115777) in Treatment of Relapsed and Refractory Lymphoma


I. To assess tumor response to R115777 (tipifarnib) in patients with relapsed aggressive
non-Hodgkin's lymphoma. (Permanently closed to accrual 6/28/06) II. To assess tumor response
to R115777 in patients with relapsed indolent non-Hodgkin's lymphoma. (Permanently closed to
accrual 9/26/07) III. To assess tumor response to R115777 in patients with uncommon
non-Hodgkin's lymphomas.

IV. To evaluate toxicity associated with this regimen in patients with relapsed
non-Hodgkin's lymphoma.


I. To evaluate known and unknown molecular markers that may predict for response to R115777
in lymphoma tissue.


Patients receive tipifarnib orally (PO) twice daily (BID) on days 1-21. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Inclusion Criteria:

- Biopsy-proven relapsed or refractory lymphomas; previous biopsies =< 6 months prior
to treatment on this protocol will be acceptable as long as there has not been
intervening therapy; if the patient has received therapy for non-Hodgkin's disease
(NHL) between the time of the last biopsy and this protocol, then a re-biopsy is

- STUDY 1: Aggressive lymphomas (permanently closed to accrual 6/28/06):

- Transformed lymphomas

- Diffuse large B cell lymphoma

- Mantle cell lymphoma

- Follicular lymphoma grade III STUDY 2: Indolent lymphomas (permanently closed to
accrual 9/26/07)

- Small lymphocytic lymphoma/chronic lymphocytic leukemia

- Follicular lymphoma, grades 1, 2

- Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
(MALT) type

- Nodal marginal zone B-cell lymphoma

- Splenic marginal zone B-cell lymphoma

STUDY 3: Uncommon lymphomas:

- Peripheral T cell lymphoma, unspecified

- Anaplastic large cell lymphoma (T and null cell type)

- Lymphoplasmacytic lymphoma

- Mycosis fungoides/ Sezary syndrome

- Relapsed Hodgkin's disease (patients must be previously treated and either have had a
transplant or not be eligible for a transplant)

- Previously treated (no limitations on the number of prior therapies); patients
with aggressive lymphoma (Study 1 - permanently closed to accrual 6/28/06)
should have received or be ineligible for potentially curable therapy including
stem cell transplant

- MEASURABLE DISEASE: Must have at least one lesion that has a single diameter of
>= 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 upper limit of normal (ULN) (if > 2 x ULN direct
bilirubin is required and should be =< 1.5 x ULN)

- Aspartate aminotransferase (AST) =< 3 x ULN (=< 5 x ULN if liver involvement is

- Serum creatinine =< 2 x ULN

- Expected survival >= 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

- 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 =< 3 weeks prior to study registration
unless the acute side effects associated with such therapy are resolved

- Therapy with myelosuppressive chemotherapy, cytotoxic chemotherapy, or biologic
therapy =< 3 weeks (6 weeks for nitrosourea or mitomycin C) or corticosteroids =< 2
weeks, prior to starting R11577; patients may be on corticosteroids or tapering off
them up until the day they start R11577 as long as it is clear that they are not
having a tumor response to the steroids or that the steroids would confuse the
interpretation of response to R11577; patients may be receiving stable (not increased
within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg
of prednisone per day if they are being given for disorders other than lymphoma such
as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or
intractable symptoms of lymphoma

- Peripheral neuropathy >= 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment

Outcome Description:

Confirmed response is at least a 50% decrease in the sum of the products of the greatest diameters (SPD) of the six largest dominant nodes or nodal masses and no increase in the size of other nodes, liver, or spleen and splenic and hepatic nodules must regress by at least 50% in the SPD and no new sites of disease.

Outcome Time Frame:

During the first 6 cycles of treatment

Safety Issue:


Principal Investigator

Thomas Witzig

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Anaplastic Large Cell Lymphoma
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Nodal Marginal Zone B-cell Lymphoma
  • Peripheral T-cell Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Recurrent Adult T-cell Leukemia/Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Splenic Marginal Zone Lymphoma
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, B-Cell, Marginal Zone
  • Lymphoma, Mantle-Cell



Mayo Clinic Rochester, Minnesota  55905
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242