Non Hodgkin Lymphoma Clinical Trial

Imetelstat Sodium in Treating Young Patients With Refractory or Recurrent Solid Tumors or Lymphoma

Summary

RATIONALE: Imetelstat sodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase I clinical trial is studying the side effects and best dose of imetelstat sodium in treating young patients with refractory or recurrent solid tumors or lymphoma.

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Full Description

OBJECTIVES:

Primary

To estimate the maximum-tolerated dose (MTD) and/or recommended phase II dose of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma.
To define and describe the toxicities of imetelstat sodium.
To characterize the pharmacokinetics of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma.

Secondary

To determine, in a preliminary manner, the antitumor effects of imetelstat sodium in children with refractory or recurrent solid tumors or lymphoma. (exploratory)
To provide preliminary assessment of the biological activity of imetelstat sodium in children with recurrent or refractory malignancies by assessing telomerase activity, telomere length, hTERT protein, hTERT mRNA, and hTR levels in patient peripheral blood mononuclear cells (PBMNC) samples pretreatment and on treatment. (Exploratory)
To assess telomerase activity, hTERT expression, telomere length, hTERT protein, hTERT mRNA, and hTR levels in patients' pretreatment tumor samples. (Exploratory)

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive imetelstat sodium IV over 2 hours on days 1 and 8. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for pharmacokinetic and correlative studies. Tumor tissue samples from diagnosis and/or subsequent tumor resections or biopsies may also be collected for correlative studies.

After completion of study therapy, patients are followed up for 30 days.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Diagnosis of refractory or recurrent solid tumors, including lymphoma

No CNS tumors or known CNS metastases (Part A, dose escalation)

CNS tumors or known CNS metastases allowed (Part B, maximum-tolerated dose or recommended phase II dose)

No prior or concurrent CNS hemorrhage on a baseline MRI within the past 14 days

All patients must have histologic verification of malignancy at original diagnosis or relapse except for:

Intrinsic brain stem tumors
Optic pathway gliomas
Pineal tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG
Measurable or evaluable disease
Disease for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
Patients with known bone marrow metastatic disease will be eligible for study provided they meet the blood count criteria and they are not known to be refractory to red cell or platelet transfusions

PATIENT CHARACTERISTICS:

Karnofsky performance status (PS) 50-100% (patients > 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years of age)
ANC ≥ 1,000/mm³
Platelet count ≥ 100,000/mm³ (transfusion-independent, defined as not receiving platelet transfusion within the past 7 days prior to enrollment)

Creatinine clearance or radioisotope GFR ≥ 70 mL/min OR a serum creatinine based on age and/or gender as follows:

0.6 mg/dL (1 to < 2 years of age)
0.8 mg/dL (2 to < 6 years of age)
1.0 mg/dL (6 to < 10 years of age)
1.2 mg/dL (10 to < 13 years of age)
1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
Bilirubin (sum of conjugated and unconjugated) ≤ 1.5 times upper limit of normal (ULN)
ALT ≤ 110 U/L (ULN for ALT is 45 U/L)
Serum albumin ≥ 2 g/dL
aPTT < 1.2 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use an effective contraception method
No uncontrolled infection
No patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

PRIOR CONCURRENT THERAPY:

Recovered from acute toxic effects of all prior anti-cancer chemotherapy, immunotherapy, or radiotherapy
At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosourea)
At least 14 days since prior long-acting growth factor (e.g., Neulasta) or ≥ 7 days since prior short-acting growth factor
At least 7 days since prior biologic or anti-neoplastic agent
At least 6 weeks since any type of prior immunotherapy (e.g., tumor vaccines)
At least 3 half-lives since last dose of a monoclonal antibody

At least 2 weeks since prior local palliative radiotherapy (small port)

At least 24 weeks since prior total-body irradiation, craniospinal radiotherapy, or radiation to ≥ 50% of the pelvis
At least 6 weeks since prior substantial bone marrow radiation
At least 12 weeks since prior transplantation or stem cell infusion with no evidence of active graft vs host disease
Prior and concurrent stable or decreasing dose of corticosteroids within the past 7 days allowed
No prior allogeneic transplant
No other concurrent investigational drug
No other concurrent anticancer agents including chemotherapy, radiotherapy, immunotherapy, or biologic therapy
No concurrent cyclosporine, tacrolimus, or other agents to prevent either graft-versus-host disease post-bone marrow transplant or organ rejection post-transplant

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT01273090

Recruitment Status:

Completed

Sponsor:

Children's Oncology Group

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There are 23 Locations for this study

See Locations Near You

UAB Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
Children's Hospital of Orange County
Orange California, 92868, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Children's National Medical Center
Washington District of Columbia, 20010, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta Georgia, 30322, United States
Children's Memorial Hospital - Chicago
Chicago Illinois, 60611, United States
Riley's Children Cancer Center at Riley Hospital for Children
Indianapolis Indiana, 46202, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda Maryland, 20892, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston Massachusetts, 2115, United States
C.S. Mott Children's Hospital at University of Michigan Medical Center
Ann Arbor Michigan, 48109, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St. Louis Missouri, 63110, United States
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
New York New York, 10032, United States
Cincinnati Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Knight Cancer Institute at Oregon Health and Science University
Portland Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh Pennsylvania, 15213, United States
St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas Texas, 75390, United States
Baylor University Medical Center - Houston
Houston Texas, 77030, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle Washington, 98105, United States
Midwest Children's Cancer Center at Children's Hospital of Wisconsin
Milwaukee Wisconsin, 53226, United States
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
Hopital Sainte Justine
Montreal Quebec, H3T 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

34

Study ID:

NCT01273090

Recruitment Status:

Completed

Sponsor:


Children's Oncology Group

How clear is this clinincal trial information?

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