Know Cancer

or
forgot password

A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

A Phase I Trial Of 2-Methoxyestradiol (2ME2), (NSC-659853) An Angiogenesis Inhibitor, In Patients With Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of 2-methoxyestradiol in patients with advanced
solid tumors.

- Determine the side effect profile of this drug in these patients.

- Determine the pharmacokinetic profile of this drug in these patients.

- Determine the changes in positron-emission tomography scans of patients treated with
this drug.

- Determine the changes in apotosis in patients treated with this drug.

OUTLINE: This is a dose-escalation study.

Patients receive oral 2-methoxyestradiol (2ME2) once on day 1 followed by 2 days of
evaluation. Patients then receive oral 2ME2 every 12 hours. Treatment continues in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of 2ME2 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity.

Patients are followed at day 30.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed solid tumor

- Metastatic or unresectable disease for which standard curative treatments do not
exist or are no longer effective

- Clinically progressive disease documented by any of the following:

- New area of malignant disease

- Progression of soft-tissue metastases

- At least 1 new metastatic deposit on technetium Tc 99m bone scintigraphy

- Increases in prostate-specific antigen

- Lesions accessible for serial biopsy

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal

- AST/ALT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

Other:

- No other concurrent uncontrolled illness

- No ongoing or active infection

- No prior allergic reactions to compounds of similar chemical or biological
composition to 2-methoxyestradiol

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 1 month before, during, and for
1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior biologic therapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, nitrosoureas, or
carboplatin)

- No concurrent chemotherapy for cancer

Endocrine therapy:

- Luteinizing-hormone releasing-hormone agonist therapy must be continued for patients
with prostate cancer except those with prior orchiectomy

Radiotherapy:

- At least 4 weeks since prior radiotherapy

- No concurrent radiotherapy for cancer

Surgery:

- See Endocrine therapy

Other:

- Recovered from prior therapy

- No other concurrent therapy for cancer

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

William Dahut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Medical Oncology Branch

Authority:

United States: Federal Government

Study ID:

CDR0000069022

NCT ID:

NCT00030095

Start Date:

September 2001

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Center for Cancer ResearchBethesda, Maryland  20892