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A Phase II Study Evaluating the Efficacy and Safety of the Farnesyl-transferase Inhibitor ZARNESTRA® in Patients With Relapsed, Refractory or Progressive Mantle Cell Lymphoma Not Appropriate for Autologous Bone Marrow Transplantation


Phase 2
18 Years
N/A
Not Enrolling
Both
Mantle Cell Lymphoma

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Trial Information

A Phase II Study Evaluating the Efficacy and Safety of the Farnesyl-transferase Inhibitor ZARNESTRA® in Patients With Relapsed, Refractory or Progressive Mantle Cell Lymphoma Not Appropriate for Autologous Bone Marrow Transplantation


Zarnestra® will be administered at 300 mg administered orally twice daily for the first 21
days of each 28-days cycle. Tipifarnib treatment stops no later than day 21 of each cycle.

Subjects will receive a total of 4 cycles of treatment. Two additional cycles might be
administered for patients showing improvement to PR after 4 cycles.

After testing the drug on 11 patients in the first stage, the trial will be terminated if 1
or fewer respond and the drug will not be considered as effective.

If two or more patients respond in the first stage, the trial goes on to the second stage to
include a total of 27 patients.


Inclusion Criteria:



- Male or female subject 18 years or older.

- Initial diagnosis of histologically confirmed mantle cell lymphoma based on the World
Health Organization 1997 classification.

- Patient not able to receive high dose autologous stem cell transplantation with
relapsed, refractory or progressive MCL after prior anti-neoplastic treatment.
Relapse or progression since previous anti-neoplastic therapy must be documented by
new lesions or objective evidence of progression of existing lesions. Biopsy is not
required.

- Ann Arbor stages I-IV.

- At least 1 measurable lymph node mass that is >1.5 cm in 2 perpendicular dimensions,
and has not been previously irradiated or has grown since previous irradiation.

- Eastern Cooperative Oncology Group [ECOG] performance status 0-2.

- The following laboratory values at screening,:

- Absolute neutrophil count (ANC) ≥ 1.0 G/L and Platelets ≥ 75 G/L

- Aspartate transaminase (AST) ≤ 2.5 x ULN; Alanine transaminase (ALT) ≤ 2.5 x
ULN; Total bilirubin ≤ 1.5 x ULN; Creatinin level ≤ 150 µmol/L

- Female subject is either post-menopausal or surgically sterilized or willing to use
an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine
device, diaphragm with spermicide, condom with spermicide, or abstinence) for the
duration of the study. Women are neither breast feeding nor pregnant for the duration
of the study. Confirmation that the subject is not pregnant must be established by a
negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained
during screening. Pregnancy testing is not required for post-menopausal or surgically
sterilized women. Male subject agrees to use an acceptable method for contraception
for the duration of the study.

- Voluntary signed informed consent before performance of any study-related procedure
not part of normal medical care, with the understanding that consent may be withdrawn
by the subject at any time without prejudice to future medical care.

- Patient with minimum life expectancy of 3 months.

Exclusion Criteria:

- Any other type of lymphoma.

- Previous treatment with Zarnestra®.

- Anti-neoplastic or radiation therapy within 2 weeks before Day 1 of Cycle 1.

- Major surgery within 2 weeks before Day 1 of Cycle 1.

- Rituximab, alemtuzumab (Mabcampath®), or other unconjugated therapeutic antibody
within 2 weeks before Day 1 of Cycle 1

- Nitrosoureas within 2 weeks before Day 1 of Cycle 1.

- Radioimmunoconjugates or toxin immunoconjugates such as ibritumomab tiuxetan
(Zevalin™), or tositumomab (Bexxar®) within 4 weeks before Day 1 of Cycle 1.

- Less than 30 days since participation in another investigational agent study on Day 1
of cycle 1. Concurrent participation in non-treatment studies is allowed, if it will
not interfere with participation in this study.

- Known or suspected allergy to imidazole drugs, such as clotrimazole, ketoconazole,
miconazole, econazole, fenticonazole, isoconazole, sulconazole, tioconazole, or
terconazole.

- Subjects not adequately recovered from any treatment-related non hematologic toxicity
(recovery is defined as NCI CTC v3.0 Grade 0 or 1).

- Symptomatic peripheral neuropathy of any grade.

- Diagnosed or treated for a malignancy other than NHL within 5 years before Day 1 of
Cycle 1, with the exception of complete resection of basal cell carcinoma, squamous
cell carcinoma of the skin, or in situ malignancy. Subjects previously diagnosed with
prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason
score ≤7, and a prostate specific antigen (PSA) ≤10 ng/mL prior to initial therapy,
(2) they had definitive curative therapy (ie, prostatectomy or radiotherapy) ≥2 years
before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no
clinical evidence of prostate cancer, and their PSA was undetectable if they
underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy.

- Active systemic infection requiring treatment.

- Previously known HIV positive serology

- Serious medical or psychiatric illness likely to interfere with participation in this
clinical study.

- Adult patient under guardian.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Efficacy measured by evaluation of the overall response rate (complete response [CR] + complete response unconfirmed [CRu] + partial response [PR]) to Zarnestra® as single agent, according to criteria based on those developed by Cheson and al.

Outcome Time Frame:

After 4 cycles

Safety Issue:

No

Principal Investigator

Catherine THIEBLEMONT, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lymphoma Study Association

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

MCL06-1

NCT ID:

NCT00847223

Start Date:

June 2007

Completion Date:

Related Keywords:

  • Mantle Cell Lymphoma
  • Mantle cell lymphoma
  • Lymphoma
  • relapsed, refractory or progressive MCL
  • Mantle cell lymphoma (relapsed, refractory or progressive)
  • Lymphoma
  • Lymphoma, Mantle-Cell

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