Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides - Full Text View

Sponsored by:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00056056

Purpose

RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.

PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.

Condition	Intervention	Phase
Lymphoma	Drug: bexarotene Drug: methoxsalen Procedure: UV light therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control
Official Title:	A Randomized, Open-Label Phase III Trial to Evaluate the Efficacy and Safety of Bexarotene (Targretin) Capsules Combined With PUVA, Compared to PUVA Treatment Alone in Patients With Mycosis Fungoides

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fungal Infections Lymphoma

Drug Information available for: Bexarotene Methoxsalen

U.S. FDA Resources

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

Primary Outcome Measures:

Cumulative dose of UVA necessary to achieve a complete clinical response (CCR) by Tumor Burden Index and appearance or disappearance of extracutaneous lesions every 4 weeks during treatment and then every 8 weeks until progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall response rate (CCR + partial response [PR]) by Tumor Burden Index and appear. or disappear. of extracutaneous lesions every 4 weeks during treatment and then every 8 weeks until progression [ Designated as safety issue: No ]
Time to relapse as measured by Logrank every 4 weeks during treatment, then every 8 weeks [ Designated as safety issue: No ]
Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression [ Designated as safety issue: No ]
Number of UVA light therapy with methoxsalen (PUVA) sessions necessary to achieve a CCR by median and range at the completion of treatment [ Designated as safety issue: No ]
Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks [ Designated as safety issue: Yes ]
Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment [ Designated as safety issue: Yes ]

Estimated Enrollment:	134
Study Start Date:	January 2003

Detailed Description:

OBJECTIVES:

Compare the cumulative dose of ultraviolet A light required to achieve a complete clinical response (CCR) in patients with mycosis fungoides treated with ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene.
Compare the overall response rate (CCR and partial response) in patients treated with these regimens.
Compare the duration of CCR and time to relapse of patients treated with these regimens.
Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
Determine the percentage of dropouts by patients treated with these regimens.
Determine the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week.
Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.

Patients are followed every 8 weeks until the first documented progression or relapse.

PROJECTED ACCRUAL: A total of 134 patients (67 per treatment arm) will be accrued for this study within 17 months.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed mycosis fungoides
- Stage IB or IIA
- Confirmed by current or prior diagnostic lesion biopsy

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

Karnofsky 60-100%

Life expectancy

Not specified

Hematopoietic

WBC at least 2,000/mm^3
Hemoglobin at least 9 g/dL

Hepatic

Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST and ALT no greater than 2.5 times ULN

Renal

Creatinine no greater than 2 times ULN
Calcium no greater than 11.5 mg/dL

Cardiovascular

No New York Heart Association grade III or IV cardiac insufficiency

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study participation* NOTE: *Women using hormonal contraception must also use a non-hormonal treatment
Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization)
Willing and able to avoid prolonged exposure to the sun
- Willing to limit sun exposure on day of PUVA therapy
No prior intolerance of or unresponsiveness to PUVA therapy
No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
No prior pancreatitis
No other concurrent serious illness or infection that would preclude study participation
No concurrent excessive alcohol consumption
No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors
No psychological, familial, sociological, or geographical condition that would preclude study compliance
No known contraindications to study drug
No known hypersensitivity to retinoids or hypervitaminosis A
No uncontrolled diabetes mellitus
No uncontrolled thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 3 months since prior interferon therapy

Chemotherapy

No prior systemic combination chemotherapy
No prior participation in another study of bexarotene
At least 3 months since prior topical chemotherapy

Endocrine therapy

At least 1 month since prior topical corticosteroids

Radiotherapy

At least 6 months since prior total skin electron beam therapy
At least 1 month since prior superficial radiotherapy

Surgery

Not specified

Other

At least 30 days since prior participation in another investigational drug study
At least 3 months since prior photopheresis
At least 1 month since prior UVB/PUVA phototherapy
At least 1 month since prior retinoid class drugs
At least 1 month since prior beta-carotene compounds
At least 1 month since other prior topical medications (e.g., tar baths)
No prior participation in this study
No other concurrent anticancer therapy
No other concurrent investigational drug therapy
No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056056

Show 26 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Sean J. Whittaker, MD

St. Thomas' Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000271933, EORTC-21011
Study First Received:	March 6, 2003
Last Updated:	June 16, 2009
ClinicalTrials.gov Identifier:	NCT00056056 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:

Anticarcinogenic Agents
Immunoproliferative Disorders
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Photosensitizing Agents
Radiation-Sensitizing Agents

Methoxsalen
Cutaneous T-cell Lymphoma
Bexarotene
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Anticarcinogenic Agents
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Sezary Syndrome
Mycosis Fungoides
Protective Agents
Pharmacologic Actions
Mycoses
Lymphatic Diseases

Photosensitizing Agents
Neoplasms
Radiation-Sensitizing Agents
Bexarotene
Methoxsalen
Therapeutic Uses
Lymphoma, T-Cell
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Dermatologic Agents
Lymphoma
Lymphoma, T-Cell, Cutaneous

ClinicalTrials.gov processed this record on July 02, 2009