Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy With or Without Gene Therapy in Treating Patients With Unresectable Recurrent Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Pharmaceutical / Industry INTROGEN-T302 UCLA-0312111-01, NCT00041626

Objectives

Primary

1. Compare the time to progression of target lesions in patients with unresectable recurrent squamous cell carcinoma of the head and neck treated with cisplatin and fluorouracil with vs without Ad5CMV-p53 gene therapy (INGN 201).

Secondary

1. Compare time to overall disease progression in patients treated with these regimens.
2. Compare overall survival in patients treated with these regimens.
3. Compare objective local and overall response rate in patients treated with these regimens.
4. Compare duration of local and overall response to these regimens in these patients.
5. Compare local and overall tumor growth control in patients treated with these regimens.
6. Compare the effectiveness of these regimens in these patients.
7. Compare the safety and tolerability of these regimens in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed recurrent squamous cell carcinoma of the head and neck
  • No distant metastases



• Local or regional disease recurrence after first-line therapy with curative intent (i.e., surgery and/or radiotherapy)
  • Any number of prior recurrences allowed



• At least 1 bidimensionally measurable lesion by CT scan, MRI, ultrasonography, or physical examination
  • No single lesion > 7.5 cm (longest diameter)
  • Maximum cumulative size of </= 10.0 cm, defined by the sum of the longest diameter of each lesion



• Disease accessible to intra-tumoral injection
  • Inaccessible disease allowed provided the following are true:
    • The sum of the longest diameter of the inaccessible portion of the disease </= 1.5 cm
    • The location of the inaccessible disease does not predictably increase the patient’s morbidity or mortality (i.e., inaccessible tracheal invasion with impending airway obstruction)



• Must have received at least 5,000 cGy of standard method radiotherapy



• Must be ineligible for standard radiotherapy or complete resection at recurrence



• Must be eligible to receive a minimum of 4 courses of chemotherapy
  • Prior exposure to platinum or fluorouracil allowed provided this therapy is still appropriate



• Adequate tumor tissue available



• No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy:

• No prior gene therapy with adenoviral vectors or p53 gene product
• No prior autologous or allogeneic organ or tissue transplantation
• No concurrent immunomodulating drugs

Chemotherapy:

• See Disease Characteristics
• More than 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy:

• No more than 6 months of prior chronic non-topical corticosteroids (prednisone or equivalent) at doses over 10 mg/day

Radiotherapy:

• See Disease Characteristics
• More than 8 weeks since prior radiotherapy for loco-regional disease

Surgery:

• See Disease Characteristics

Other:

• More than 4 weeks since prior systemic anticancer therapy
• More than 4 weeks since prior participation in another clinical trial of non-approved experimental agents or procedures
• No concurrent non-steroidal anti-inflammatory drugs or salicylates
  • Aspirin allowed at cardioprotective doses (≤ 83 mg/day)
• No concurrent folate
• No concurrent therapy that would interfere with biologic activity, toxicity, efficacy, or evaluation of study therapy

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL

Hepatic:

• Bilirubin normal
• AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• Hepatitis B surface antigen negative
• Hepatitis C antibody negative

Renal:

• Creatinine normal
• Creatinine clearance ≥ 60 mL/min

Other:

• Must not have contact with individuals who have undergone prior tissue or organ transplantation OR who are suffering from severe immunodeficiency disease (acquired or congenital) during and for 4 weeks after study participation
• No active uncontrolled infection
• No other malignancy within the past 2 years except curatively treated carcinoma in situ of the cervix, stage I cervical cancer, stage I melanoma, or basal cell carcinoma
• No other serious medical condition that would preclude study participation
• HIV-1 and -2 negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception during and for 6 months after study participation

Expected Enrollment

A total of 255 patients (170 for arm I and 85 for arm II) will be accrued for this study within 41 months.

Outcomes

Time to locoregional disease progression

Time to overall disease progression
Overall survival
Objective locoregional and overall response rate
Duration of locoregional response and complete locoregional response
Duration of overall response and overall complete response
Locoregional and overall tumor growth control rate
Cancer morbidity
Quality of life as measured by EORTC QLQ-C30 v3.0 and H&N35 questionnaires

Outline

This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cisplatin IV and docetaxel IV on day 1 and fluorouracil IV continuously over 96 hours on days 1-4. Patients also receive Ad5CMV-p53 gene therapy (INGN 201) intratumorally on days 2, 3, and 4.



• Arm II: Patients receive cisplatin, docetaxel and fluorouracil as in arm I.

Treatment in both arms repeats every 28 days for 12 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed at 28 days and then every 6 weeks thereafter.

Trial Contact Information

Trial Lead Organizations

Introgen Therapeutics, Incorporated

Julie Sicam, Study coordinator		Ph: 713-797-9960

U.S.A.
Texas
	Houston
	Introgen Therapeutics, Incorporated
		Julie Sicam	Ph:  713-797-9960

Registry Information
Official Title		A Phase III, Multi-Center, Open-Label, Randomized Study to Compare the Effectiveness and Safety of Intratumoral Administration of INGN 201 in Combination with Chemotherapy Versus Chemotherapy Alone in Patients with Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Registered in ClinicalTrials.gov		NCT00041626
Date Submitted to PDQ		2002-04-12
Information Last Verified		2007-01-24

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