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Chronic Myeloproliferative DisordersPhase 1NCT00104923

Fenretinide in Treating Patients With Refractory or Relapsed Hematologic Cancer

A Phase 1 study testing fenretinide in people with Chronic Myeloproliferative Disorders and Leukemia, run by California Cancer Consortium at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fenretinide in a different way may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
fenretinide
Type of treatment
Injection or infusion
How many people
29 participants
Where
4 sitesUnited States
Study dates
Feb 2005to Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed diagnosis of 1 of the following hematologic malignancies:
  • Non-Hodgkin's lymphoma (NHL)
  • Hodgkin's lymphoma
  • Multiple myeloma
  • Acute lymphoblastic leukemia
  • Acute myeloid leukemia
  • Chronic hematologic malignancy with a poor prognosis (e.g., failed 3 prior standard therapies), including any of the following:
  • Chronic lymphocytic leukemia
  • Chronic myelogenous leukemia
  • Indolent NHL
  • Myeloproliferative disorders
  • Refractory or relapsed disease, as defined by 1 of the following:
  • Resistant to standard therapy for refractory or relapsed disease
  • Progressed after standard therapy for advanced disease
  • No effective treatment exists
  • Measurable or evaluable disease
  • No active CNS disease
  • Previously treated leptomeningeal disease or brain metastases allowed provided there is no evidence of remaining cancer by positron-emission tomography, MRI, or spinal fluid cytology

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3 (unless due to bone marrow involvement of disease)
  • Platelet count ≥ 75,000/mm^3 (unless due to bone marrow involvement of disease)
  • Hemoglobin ≥ 8.0 g/dL (transfusion allowed)
  • No coagulation disorders

Hepatic

  • AST and ALT < 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for patients with liver metastasis)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN

Cardiovascular

  • No major cardiovascular disease

Pulmonary

  • No major respiratory disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception prior to study entry, during study, and for at least 6 months after study participation
  • No uncontrolled systemic infection
  • No uncontrolled hypertriglyceridemia (i.e., triglyceride level > 500 mg/dL)
  • No known HIV positivity
  • No known allergy to egg products
  • No known familial hyperlipidemia disorders
  • No previously undiscovered hypertriglyceridemia
  • No poorly controlled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • More than 2 weeks since prior chemotherapy except hydroxyurea
  • No concurrent hydroxyurea during study drug administration
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent hormone-ablative agents
  • No concurrent steroids
  • No concurrent tamoxifen or any of its analogues

Radiotherapy

  • No prior cranial radiotherapy
  • More than 2 weeks since prior radiotherapy

Surgery

  • More than 20 days since prior surgery except for biopsy

Other

  • Recovered from all prior therapy
  • More than 2 weeks since prior investigational agents
  • No other concurrent investigational agents
  • No other concurrent antineoplastic therapy
  • No other concurrent antioxidants
  • No concurrent herbal or other alternative therapies
  • No concurrent vitamin supplements (e.g., vitamin A, ascorbic acid, or vitamin E)
  • Standard dose multivitamin allowed
  • No other concurrent medications that may act as modulators of intracellular ceramide levels or ceramide cytotoxicity, sphingolipid transport, or p-glycoprotein or multidrug resistance protein 1 (MRP1) drug/lipid transporters, including any of the following:
  • Cyclosporine or any of its analogues
  • Verapamil
  • Ketoconazole
  • Chlorpromazine
  • Mifepristone
  • Indomethacin
  • Sulfinpyrazone
  • No concurrent medications that may cause pseudotumor cerebri, including any of the following:
  • Tetracycline
  • Nalidixic acid
  • Nitrofurantoin
  • Phenytoin
  • Sulfonamides
  • Lithium
  • Amiodarone
  • No concurrent medication to control hypertriglyceridemia

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

    Bethesda, Maryland, 20892-1182

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410-1894

Other trials in United States

About this study

Official title: Phase I Trial of Intravenous Fenretinide (4-HPR) for Patients With Hematologic Malignancies

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fenretinide in a different way may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of intravenous fenretinide in treating patients with refractory or relapsed hematologic cancer.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of intravenous emulsified fenretinide in patients with refractory or relapsed hematologic malignancies.
  • Determine the toxic effects of this drug in these patients.
  • Determine the pharmacokinetics and in vivo activity of this drug in these patients.
  • Determine, preliminarily, disease or tumor response in patients treated with this drug.

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

Patients receive emulsified fenretinide IV continuously over 5 days. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete or partial response may continue to receive fenretinide at the discretion of the study chair.

Cohorts of 1 patient receive accelerated escalating doses of fenretinide until 2 patients experience moderate toxicity (cumulative across all dose levels) OR 1 patient experiences dose-limiting toxicity (DLT). After completion of the accelerated dose-escalation portion, the standard dose-escalation portion begins. Cohorts of 3-6 patients receive escalating doses of fenretinide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience DLT. At least 6 patients are treated at the MTD. An additional 12 patients are treated at the MTD.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Being tested
fenretinide
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent small lymphocytic lymphoma, recurrent mantle cell lymphoma, Waldenstrom macroglobulinemia, adult grade III lymphomatoid granulomatosis, recurrent adult grade III lymphomatoid granulomatosis, secondary acute myeloid leukemia, recurrent adult Burkitt lymphoma, recurrent adult immunoblastic large cell lymphoma, refractory chronic lymphocytic leukemia, recurrent adult lymphoblastic lymphoma, recurrent adult Hodgkin lymphoma, refractory multiple myeloma
Medical subject headings
Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Congenital Abnormalities, Lymphoma, Follicular, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fenretinideDrug

    Current dose level as an IV continuous infusion via central line over 5 days. Cycle is repeated every 3 weeks for up to 6 cycles

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To determine the maximum tolerated dose of fenretinide

    Measured: participants will be followed for the duration of cycle 1, which is expected to be 3 weeks.

  2. To describe the toxicities of fenretinide

    Measured: participants will be followed for the duration of treatment, which is expected to be 18 weeks or less

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104923
Sponsor's protocol ID
CDR0000413887
Other IDs
P30CA033572, CCC-PHI-42, NCI-6528, LAC-USC-0C-04-3, NCI-06-C-0227, NCI-P6820
Status last verified
Jul 2017
First submitted
3 Mar 2005
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fenretinide in people with Chronic Myeloproliferative Disorders and Leukemia, run by California Cancer Consortium at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose of fenretinide (time frame: participants will be followed for the duration of cycle 1, which is expected to be 3 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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