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CDDO in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma
This study has been completed.
First Received: July 13, 2006   Last Updated: February 6, 2009   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00352040
  Purpose

RATIONALE: Drugs used in chemotherapy, such as CDDO, 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 I trial is studying the side effects and best dose of CDDO in treating patients with metastatic or unresectable solid tumors or lymphoma.


Condition Intervention Phase
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: CDDO
Other: laboratory biomarker analysis
Other: pharmacological study
Phase I

MedlinePlus related topics: Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: CDDO Phase I Study in Patients With Solid Tumors and Lymphomas

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose, dose-limiting toxicity, and toxicity profile [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Antitumor activity [ Designated as safety issue: No ]
  • In vivo molecular and biological effects of CDDO as measured by changes in biomarkers of apoptosis and cell cycle arrest (e.g., caspase 3, caspase 8, and caspase 9 cleavage products, p21, and poly-ADP ribose polymerase [PARP] cleavage products) [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: May 2006
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Define the maximum tolerated dose of CDDO in patients with metastatic or unresectable solid tumors or lymphoma.
  • Define the dose-limiting toxicities and toxicity profile associated with administration of CDDO in these patients.
  • Define the pharmacokinetics of CDDO.

Secondary

  • Obtain preliminary evidence of antitumor activity of CDDO in patients with solid tumors or lymphoma.
  • Evaluate in vivo molecular and biological effects of CDDO, by assessing tumor biopsies and leukocytes (buffy coat) for statistically significant differences in pre-treatment vs day 5 post-treatment changes in biomarkers of apoptosis and cell cycle arrest.

OUTLINE: This is a dose-escalation study.

Patients receive CDDO IV continuously on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of CDDO until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. At least 10 patients are treated at the MTD.

Patients undergo blood collection periodically and possible tumor biopsies for pharmacokinetic and biomarker correlative studies.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumors or lymphoma meeting all of the following criteria:

    • Metastatic or unresectable disease
    • No therapy with survival benefit for disease available
    • No standard curative or palliative measures available
  • Measurable or evaluable disease
  • No known brain metastases

    • Patients with metastatic brain disease that has remained stable for ≥ 6 months after treatment of the metastases without steroids or antiseizure medications may be allowed at the discretion of the principal investigator

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
  • Life expectancy > 3 months
  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 2 months after completion of study treatment
  • No history of allergic reactions attributed to other synthetic triperinoids or compounds of similar chemical or biologic composition to CDDO, such as derivative compounds CDDO-Im and CDDO-Me
  • No active or uncontrolled infection
  • No immune deficiencies or confirmed diagnosis of HIV infection, hepatitis B, or hepatitis C
  • No uncontrolled diabetes
  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No myocardial infarction within the past 6 months
  • No uncontrolled cardiac arrhythmia
  • No psychiatric illness or social situations that would limit study compliance
  • No other clinically significant illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • More than 4 weeks since prior chemotherapy or biologic therapy (6 weeks for nitrosoureas or mitomycin C and 8 weeks for UCN-01) and recovered
  • At least 1 month since prior radiation therapy or major surgery
  • At least 2 weeks since prior participation in a phase 0 study
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00352040

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Investigator: Janelle Bingham, RN NCI - Medical Oncology Branch
Principal Investigator: Shivaani Kummar, MD NCI - Medical Oncology Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000483142, NCI-06-C-0151, NCI-P6704, NCI-7396
Study First Received: July 13, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00352040     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult grade III lymphomatoid granulomatosis
recurrent mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
Waldenstrom macroglobulinemia
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
small intestine lymphoma
splenic marginal zone lymphoma
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma

Study placed in the following topic categories:
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma
Ileal Diseases
Follicular Lymphoma
Duodenal Neoplasms
Mycoses
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Digestive System Neoplasms
Waldenstrom Macroglobulinemia
B-cell Lymphomas
Leukemia, T-Cell
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell, Cutaneous
Gastrointestinal Diseases
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Sezary Syndrome
Mycosis Fungoides
Lymphoblastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Ileal Neoplasms
Cutaneous T-cell Lymphoma

Additional relevant MeSH terms:
Jejunal Neoplasms
Digestive System Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Ileal Diseases
Intestinal Neoplasms
Duodenal Neoplasms
Lymphatic Diseases
Neoplasms
Digestive System Diseases
Neoplasms by Site
Ileal Neoplasms
Jejunal Diseases
Gastrointestinal Neoplasms
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Duodenal Diseases

ClinicalTrials.gov processed this record on May 07, 2009