clinical study at MD

[Guest guest]

Decitabine

in Treating Patients With Metastatic Papillary Thyroid Cancer or

Follicular Thyroid Cancer Unresponsive to Iodine I 131

This study is currently recruiting

patients.

Sponsored by

M.D. Cancer Center

National Cancer Institute (NCI)

Purpose

RATIONALE: Iodine I 131 (radioactive iodine) kills thyroid

cancer cells. Metastatic thyroid cancer cells can lose the ability to be

treated with radioactive iodine. Decitabine may help thyroid cancer cells

regain the ability to respond to treatment with radioactive iodine.

PURPOSE: Phase II trial to study the effectiveness of decitabine in

treating patients who have metastatic papillary thyroid cancer or

follicular thyroid cancer that has stopped responding to radioactive

iodine.

Condition Treatment or InterventionPhase

recurrent thyroid cancer

stage IV follicular thyroid cancer

stage IV papillary thyroid cancer

Drug: decitabine

Drug: iodine I 131

Procedure: chemotherapy

Procedure: isotope therapy

Procedure: radiation therapy

Phase II

MedlinePlus related topics:

Thyroid Cancer

Study Type: Interventional

Study Design: Treatment

Official Title: Phase II Study of Decitabine in Patients With Metastatic

Papillary Thyroid or Follicular Thyroid Cancer Unresponsive to Iodine I

131

Further Study Details:

OBJECTIVES: Primary

· Determine

whether decitabine can restore iodine I 131 (^131I) uptake in patients

with metastatic papillary thyroid or follicular thyroid cancer lesions

that are undetectable by low-dose iodine ^131I scanning.

Secondary

· Determine

the efficacy of ^131I therapy, administered after restoration of ^131I

uptake by decitabine, in these patients.

· Determine

the effect of decitabine on clinical and molecular markers of thyroid

cancer cell differentiation in these patients.

· Determine

the safety and tolerability of decitabine in patients undergoing thyroid

hormone withdrawal-induced hypothyroidism and^ 131I therapy.

OUTLINE: This is an open-label, multicenter study.

Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 of weeks

1 and 2 (course 1). On week 3, patients undergo iodine I 131 (^131I)

scanning using thyrotropin alfa injections. Patients whose scan does not

demonstrate iodine uptake continue suppressive thyroid hormone therapy

but receive no further study therapy. These patients undergo study follow

up.

Patients whose scan demonstrates iodine uptake undergo thyroid hormone

withdrawal on weeks 4-8 and receive a second course of decitabine (as in

course 1) on weeks 7 and 8. Patients then receive ^131I therapy on week

9.

Patients are followed at 3 months.

PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this

study within 4-18.5 months.

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible

for Study: Both

Criteria

DISEASE CHARACTERISTICS:

· Histologically

confirmed papillary thyroid or follicular thyroid carcinoma

· Differentiated

disease

· Metastatic

disease documented by ultrasound, CT scan (without iodinated contrast),

or MRI

· All

metastatic disease foci = 10 mm in all dimensions

· Previously

treated with total or near-total thyroidectomy AND at least 1 course of

iodine I 131 (^131I) (=29.9 mCi)

· Must

have undergone whole body

· I

scan* 1-3 days after administration of = 5.5 mCi of

· I

demonstrating no visible iodine uptake within the lesions

· Must

have 24-hour urine iodine excretion = 500 mcg within 1 week of ^131I scan

NOTE: *Scanning was performed after a two-dose regimen of thyrotropin

alfa

· Must

be receiving thyroid hormone therapy AND have thyroid-stimulating hormone

level = 0.5 mU/L

· No

known brain metastases

PATIENT CHARACTERISTICS: Age

· 18

and over

Performance status

· ECOG

0-2 OR

· Karnofsky

60-100%

Life expectancy

· More

than 6 months

Hematopoietic

· Absolute

neutrophil count = 1,500/mm^3

· Platelet

count = 100,000/mm^3

· WBC

= 3,000/mm^3

Hepatic

· AST

and ALT = 2.5 times upper limit of normal

· Bilirubin

normal

Renal

· Creatinine

normal OR

· Creatinine

clearance = 60 mL/min

Cardiovascular

· No

symptomatic congestive heart failure

· No

unstable angina pectoris

· No

cardiac arrhythmia

Other

· Not

pregnant or nursing

· Negative

pregnancy test

· Fertile

patients must use effective contraception

· No

prior allergic reaction attributed to compounds of similar chemical or

biological composition to decitabine

· No

concurrent uncontrolled illness

· No

active or ongoing infection

· No

psychiatric illness or social situation that would preclude study

compliance

PRIOR CONCURRENT THERAPY: Biologic therapy

· Not

specified

Chemotherapy

· No

prior cytotoxic chemotherapy for thyroid cancer

Endocrine therapy

· See

Disease Characteristics

Radiotherapy

· See

Disease Characteristics

· At

least 6 months since prior external beam radiotherapy administered for

locoregional disease in the thyroid bed or cervical or upper mediastinal

lymph node regions (no more than 6,000 cGy)

· More

than 6 months since other prior radiotherapy and recovered

· More

than 6 months since prior therapeutic

· I

> 10 mCi OR

· More

than 18 months since prior cumulative ^131I activity of at least 500 mCi

· More

than 3 months since prior IV or oral iodinated contrast for radiographic

studies*

· More

than 6 months since prior intrathecal iodinated contrast* NOTE: *Unless

24-hour urinary iodine excretion is = 500 mcg

Surgery

· See

Disease Characteristics

Other

· More

than 12 months since prior amiodarone*

· No

concurrent combination antiretroviral therapy for HIV-positive patients

· No

other concurrent anticancer therapy

· No

other concurrent investigational agents NOTE: *Unless 24-hour urinary

iodine excretion is = 500 mcg

Location and Contact Information

Colorado

University of Colorado Cancer Center at University of Colorado Health

Sciences Center, Aurora, Colorado, 80010, United States; Recruiting

Haugen, MD

District of Columbia

Lombardi Cancer Center at town University Medical Center,

Washington, District of Columbia, 20007, United States; Recruiting

Jonklaas, MD

jj@...

Maine

Maine Center for Cancer Medicine and Blood Disorders - Scarborough,

Scarborough, Maine, 04074, United States; Recruiting

J. Ervin, MD

Ohio

M. Barrett Cancer Center at University Hospital, Cincinnati,

Ohio, 45219, United States; Recruiting

Kim, MD

paul.kim@...

Texas

University of Texas - MD Cancer Center, Houston, Texas,

77030-4009, United States; Recruiting

I. Sherman, MD

sisherma@...

Study chairs or principal investigators

I. Sherman, MD, Study Chair, M.D. Cancer Center

More Information

Clinical trial summary from the

National Cancer Institute's PDQ® database

Study ID Numbers CDR0000368467; MDA-2003-0308; NCI-5954

Record last reviewed May 2004

NLM Identifier NCT00085293

ClinicalTrials.gov processed this record

on 2004-07-22