Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
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Purpose
This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Thyroid Cancer Stage IVA Follicular Thyroid Cancer Stage IVA Papillary Thyroid Cancer Stage IVB Follicular Thyroid Cancer Stage IVB Papillary Thyroid Cancer Stage IVC Follicular Thyroid Cancer Stage IVC Papillary Thyroid Cancer |
Drug: decitabine Radiation: iodine I 131 Biological: recombinant thyrotropin alfa Radiation: fludeoxyglucose F 18 Procedure: positron emission tomography |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine |
- Restoration of radioiodine uptake in metastatic lesions as demonstrated by diagnostic whole-body scanning after decitabine administration [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
- Efficacy of subsequent radioiodine therapy in terms of change in serum thyroglobulin level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Efficacy of subsequent radioiodine therapy in terms of change in serum thyroglobulin level [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Efficacy of subsequent radioiodine therapy in terms of complete response (CR)/partial response (PR)/stable disease (SD) of any radiographic disease [ Time Frame: 3 months ] [ Designated as safety issue: No ]The 95% confidence intervals should be provided.
- Efficacy of subsequent radioiodine therapy in terms of CR/PR/SD of any radiographic disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]The 95% confidence intervals should be provided.
- Change in fludeoxyglucose (FDG) uptake measured by positron emission tomography (PET) in metastatic tumor sites before and after DNA-methyltransferase inhibitor therapy (optional) [ Time Frame: Baseline to 3 weeks ] [ Designated as safety issue: No ]
- Frequency of adverse events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 37 |
| Study Start Date: | May 2004 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
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. |
Drug: decitabine
Given IV
Other Names:
Radiation: iodine I 131
Undergo thyrotropin-alfa stimulated radioactive iodine scan
Other Names:
Biological: recombinant thyrotropin alfa
Undergo thyrotropin-alfa stimulated radioactive iodine scan
Other Name: Thyrogen
Radiation: fludeoxyglucose F 18
Optional correlative studies
Other Names:
Procedure: positron emission tomography
Optional correlative studies
Other Names:
|
Detailed Description:
PRIMARY OBJECTIVE:
I. 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 OBJECTIVES:
I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by decitabine, in these patients.
II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients.
III. 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 and 6 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
- Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan
Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks:
- Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan
- Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L
- No known brain metastases
Performance status:
- ECOG 0-2 OR Karnofsky 60-100%
Hematopoietic:
- Absolute neutrophil count >= 1,500/mm3;
- Platelet count >= 100,000/mm3;
- WBC >= 3,000/mm3
Hepatic:
- AST and ALT =< 2.5 times upper limit of normal;
- Bilirubin normal
Renal:
- Creatinine not elevated OR
- Creatinine clearance >= 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure;
- No unstable angina pectoris;
- No cardiac arrhythmia
- 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
- No prior cytotoxic chemotherapy for thyroid cancer
- At least 6 months since prior external beam radiotherapy administered for locoregional disease in the thyroid bed or to the 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 131I > 10 mCi
- More than 18 months since prior cumulative 131I activity of at least 500 mCi
- More than 12 months since prior amiodarone (Unless 24-hour urinary iodine excretion is =< 500 mcg)
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- More than 6 months since prior intrathecal iodinated contrast (Unless 24-hour urinary iodine excretion is =< 500 mcg)
- More than 3 months since prior IV or oral iodinated contrast for radiographic studies (Unless 24-hour urinary iodine excretion is =< 500 mcg)
Contacts and Locations| United States, Colorado | |
| University of Colorado at Denver Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Steven Sherman | M.D. Anderson Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00085293 History of Changes |
| Other Study ID Numbers: | NCI-2009-00033, 2003-0308, CDR0000368467, 5954, N01CM62207 |
| Study First Received: | June 10, 2004 |
| Last Updated: | April 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Thyroid Diseases Adenocarcinoma, Follicular Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Iodine Cadexomer iodine |
Decitabine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013