Expired Study
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Houston, Texas 77030


Purpose:

RATIONALE: Drugs used in chemotherapy, such as 17-AAG, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well 17-AAG works in treating patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or Hodgkin's lymphoma.


Study summary:

OBJECTIVES: Primary - Determine the complete and partial response rates and time to treatment failure in patients with relapsed or refractory anaplastic large cell lymphoma, mantle cell lymphoma, or classical Hodgkin's lymphoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG). Secondary - Determine the safety of this drug in these patients. - Determine the biologic effect of this drug on selected molecular targets in primary lymphoma cells from these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease type (anaplastic large cell lymphoma vs mantle cell lymphoma vs Hodgkin's lymphoma). Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing disease regression after completion of 8 courses may receive 2 additional courses of treatment beyond their maximal response. After completion of study treatment, patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 36-105 patients (12-35 per stratum) will be accrued for this study within 2 years.


Criteria:

Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed relapsed/refractory mantle cell lymphoma (MCL), anaplastic large cell lymphoma (ALCL), or classical Hodgkin's lymphoma (HL). 2. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than or equal to 20 mm. 3. Patients must have received at least one prior regimen and are not candidates for stem cell transplantation. 4. Number of prior therapies: a) Primary refractory disease: Patients must have not received more than 3 prior regimens (salvage therapy followed immediately by stem cell transplant is considered one regimen). b) Relapsed from CR: no limit to number of prior treatment regimens. 5. Single agent monoclonal antibody, cytokine therapy, or involved field radiation therapy will not be counted in the number of prior therapies (because these treatments are repeatedly administered and are devoid of serious toxicity). All prior treatments will be recorded. Patients who received prior antibody therapy within 3 months of 17-AAG treatment will be identified. 6. Patients must have fully recovered from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, autologous stem cell transplantation (ASCT), or investigational drugs 7. Age greater than or equal to 16 years. Because no dosing or adverse event data are currently available on the use of 17-AAG in pediatric patients, children who are younger than 16 years old are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. 8. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%). 9. Patients must have normal organ and marrow function as defined below: a) absolute neutrophil count >/= 1,500/mL b) platelets >/= 75,000/mL c) total bilirubin within normal institutional limits d) AST(SGOT)/ALT(SGPT) </= 1.5 X institutional upper limit of normal e) creatinine within normal institutional limits. 10. The effects of 17-AAG on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Similarly, should a female partner of a male patient become pregnant while he is on study, 11. Continuation from # 11: he should notify his treating physician immediately. 12. Understand and provide signed informed consent. 13. Patients receiving warfarin should be able to switch to low molecular weight heparin while receiving 17-AAG therapy Exclusion Criteria: 1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C, and 12 weeks for radio-immunotherapy) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. 2. Patients may not be receiving any other investigational agents. 3. Patients with known CNS lymphoma should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 4. Prior allogeneic stem cell transplant because of their poor prognosis (Prior autologous stem cell transplant is not an exclusion). 5. Known history of HIV infection or AIDS. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Furthermore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with 17-AAG. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 7. History of allergic reaction to eggs, because 17-AAG is formulated using egg phospholipid. 8. Patients with currently "active" second malignancy other than non-melanoma skin cancer or carcinoma in-situ of the cervix are not to be registered. Patients are not considered to have a currently "active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse. 9. Pregnant and lactating nursing women are excluded from this study because of unknown risks of 17-AAG to fetus and infants 10. Patients with pulmonary lymphoma will be excluded. 11. Patients with symptomatic pulmonary disease requiring medication. (dyspnea, dyspnea on exertion, paroxysmal nocturnal dyspnea, oxygen requirement and significant pulmonary disease, including chronic obstructive/restrictive pulmonary disease). 12. Patients pulmonary status is sufficiently compromised, i.e., Carbon Monoxide Diffusing Capacity (DLCO) less than or equal to 80%. 13. Patients with a prior history of chest radiation, a prior history of cardiac or pulmonary toxicity after receiving anthracyclines such as doxorubicin, daunorubicin, mitoxantrone, bleomycin or carmustine/bis-chloronitrosourea (BCNU). 14. Patients with greater than or equal to grade 2 pulmonary or cardiac symptoms prior to study entry. 15. The use of concomitant medications that prolong or may prolong QTc. 16. Patients who have significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions (see Appendix I), history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina. 17. Patients who have a history of serious ventricular arrhythmia (VT or VF, >/= 3 beats in a row), QTc >/= 450 msec for men and 470 msec for women, or LVEF </= 40% by MUGA. 18. No history of prior radiation that potentially included the heart in the field (e.g.,mantle). 19. No active ischemic heart disease within 12 months. 20. No history of uncontrolled dysrhythmias or requiring antiarrythmic drugs. 21. No congenital long QT syndrome. 22. No left bundle branch block.


NCT ID:

NCT00117988


Primary Contact:

Study Chair
Anas Younes, MD
M.D. Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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