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Melanoma (Skin)Phase 1NCT00005057

Gene Therapy and Ganciclovir in Treating Patients With Stage IV Melanoma

A Phase 1 study testing adenovirus RSV-TK and ganciclovir in people with Melanoma (Skin), run by National Human Genome Research Institute (NHGRI) at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Inserting a modified herpesvirus gene into a person's melanoma cells may make the cancer more sensitive to the antiviral agent ganciclovir. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have stage IV melanoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
adenovirus RSV-TK and ganciclovir
How many people
Not given
Where
3 sitesUnited States
Study dates
Mar 2000to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Histologically confirmed advanced stage IV malignant melanoma M1 All pathologic subtypes eligible Tridimensionally measurable disease At least 1 discreet easily accessible and measurable cutaneous or subcutaneous lesion of a volume no greater than 3 cm3 by physical examination using Vernier calipers Ulcerated or necrotic lesions may not serve as index lesion Not a candidate for curative surgical resection Visceral metastases, including brain lesions, eligible provided no rapidly progressive CNS metastases likely to result in death within 3 months

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Absolute neutrophil count at least 1,800/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: BUN no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 70 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other clinically significant medical disease that is poorly controlled and/or expected to impact patient survival or that would preclude study therapy No significant cognitive impairment No serious active infection requiring intravenous antibiotic or antiviral therapy No clinical AIDS No primary immunodeficiencies No other concurrent active malignancy No history of sensitivity to ganciclovir or other antiviral drugs of this family No prior severe reaction to adenovirus or herpes virus infection (e.g., toxic epidermal necrolysis or Stevens-Johnson syndrome)

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biological response modifier therapy (e.g., interleukin-2, interferon) and recovered No prior gene therapy using adenoviral based vectors, chimeric adenoviral based vectors, HSV-tk or other thymidine kinase based therapy No concurrent biological response modifier therapy No other concurrent gene therapy including ribozyme and antisense based therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas, melphalan, or mitomycin) and recovered No concurrent antineoplastic chemotherapy Endocrine therapy: Concurrent replacement or therapeutic corticosteroids allowed Radiotherapy: Prior radiotherapy allowed provided index lesion not within radiation field Recovered from prior radiotherapy No concurrent radiotherapy except for CNS metastases provided index lesion not within radiation field Surgery: See Disease Characteristics Recovered from prior surgery Other: No other concurrent ganciclovir, acyclovir, or similar antiviral drug No concurrent immunosuppressive therapy (e.g., organ allograft)

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Clinical Genetherapy Branch

    Bethesda, Maryland, 20892

  • Metabolism Branch

    Bethesda, Maryland, 20892

  • Baylor College of Medicine

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I Study of Intralesional Administration of an Adenovirus Vector Expressing the HSV-1 Thymidine Kinase Gene (AdV.RSV-TK) in Combination With Escalating Doses of Ganciclovir in Patients With Cutaneous Metastatic Malignant Melanoma

RATIONALE: Inserting a modified herpesvirus gene into a person's melanoma cells may make the cancer more sensitive to the antiviral agent ganciclovir.

PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have stage IV melanoma.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of ganciclovir administered IV every 12 hours for 7 days in combination with adenovirus RSV-TK administered by direct intralesional injection in patients with cutaneous or subcutaneous metastatic malignant melanoma. II. Determine the dose limiting toxicities of this regimen in this patient population. III. Evaluate the response (both local and at distant metastatic sites), duration of response, response by ganciclovir dose, and any impact local treatment with adenovirus RSV-TK and ganciclovir "suicide" gene therapy may have on overall survival in these patients.

OUTLINE: This is a dose escalation study of ganciclovir. Patients are stratified according to response of the index lesion and other metastatic disease sites. Patients receive an intratumoral injection of adenovirus RSV-TK on day 1. Ganciclovir IV is administered every 12 hours on days 3-10 for a total of 14 doses. Patients sustaining a partial response (PR) or complete response (CR) may be retreated 2 weeks after documented PR or CR. Cohorts of 3-6 patients receive escalating doses of ganciclovir until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed at 3 weeks, 4 weeks, 60 days, then every 2 months for 6 months, and then every 3 months for 1.5 years.

PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.

Conditions
Melanoma (Skin)
Being tested
adenovirus RSV-TK, ganciclovir
Keywords
stage IV melanoma, recurrent melanoma, lentigo maligna malignant melanoma, superficial spreading malignant melanoma, acral lentiginous malignant melanoma, nodular malignant melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adenovirus RSV-TKBiological

  • ganciclovirDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2004 (estimated)
  2. Study startMar 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005057
Sponsor's protocol ID
CDR0000067654
Other IDs
NCI-98-C-0140C
Status last verified
Dec 2002
First submitted
6 Apr 2000
Last updated
29 Apr 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing adenovirus RSV-TK and ganciclovir in people with Melanoma (Skin), run by National Human Genome Research Institute (NHGRI) at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.

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