AzTrials
AzTrials

Melanoma (Skin)Phase 2MGFOT1NCT00560118

Fotemustine in Treating Patients With Metastatic Melanoma

A Phase 2 study testing fotemustine in people with Melanoma (Skin), run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Melanoma (Skin)
What is being tested?
fotemustine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteFrance
Study dates
8 Aug 2003to 31 Aug 2008
Phase
Phase 2
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic malignant melanoma, meeting the following criteria:
  • Metastatic lymph nodes or skin allowing for surgical resection
  • At least 1 metastatic lesion (lymph nodes, skin, visceral, brain)
  • Measurable or evaluable disease

PATIENT CHARACTERISTICS:

  • WHO performance status 0-2
  • ANC > 2 x 10^9/L
  • Platelet count > 100 x 10^9/L
  • Transaminases ≤ 2.5 times normal
  • Alkaline phosphate ≤ 2.5 times normal
  • Total bilirubin normal
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No severe uncontrolled infection
  • No other prior or concurrent malignancy (except basal cell or squamous cell carcinoma in situ of the cervix that was curatively treated)

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • At least 2 weeks since prior adjuvant therapy
  • At least 4 weeks since prior radiotherapy
  • At least 30 days since prior participation in another clinical trial
  • No prior or concurrent prophylactic phenytoin

Trial locations and contacts

1 site in 1 country.

France1 site

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

Other trials in France

About this study

Official title: Phase II Study of the Predictive Value of the Expression of Tumoral MGMT With Respect to the Therapeutic Response of Fotemustine in Patients With Metastatic Malignant Melanoma

RATIONALE: Drugs used in chemotherapy, such as fotemustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This phase II trial is studying fotemustine to see how well it works in treating patients with metastatic melanoma.

Read the detailed description

OBJECTIVES:

Primary

  • Assess the relationship between MGMT expression and response to fotemustine in patients with metastatic malignant melanoma.

Secondary

  • Establish a value for MGMT expression below which fotemustine has a strong probability of effectiveness.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising fotemustine IV over 1 hour on days 1, 8, and 15. Beginning 5 weeks later, patients achieving stable or objective response receive maintenance chemotherapy comprising fotemustine IV over 1 hour once every 3 weeks for 6 courses.

Tissue samples are collected at baseline to assess level of MGMT expression by PCR.

After completion of study treatment, patients are followed every 2 months.

Conditions
Melanoma (Skin)
Being tested
fotemustine
Keywords
recurrent melanoma, stage IV melanoma
Medical subject headings
Melanoma

What participants receive

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

  • fotemustineDrug

    Also called experimental arm

Study groups in NCT00560118
Study groupRoleWhat they receive
FotemustineExperimentalInduction treatment Fotémustine 100mg / m² IV sur 1 h J1, J8, J15 Traitement d'entretien : Fotémustine 100 mg / m² IV sur 1 h - J1 = J21
Receives: Drug: fotemustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship between MGMT expression and response to fotemustine

    response with criteria OMS

    Measured: from date of inclusion to death of patient

  2. Relationship between MGMT expression and response to fotemustine

    response with criteria OMS

    Measured: from date of inclusion to progression documentation

Timeline

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

  1. First posted19 Nov 2007 (estimated)
  2. Study start8 Aug 2003
  3. Primary completion31 Aug 2008
  4. Study completion31 Aug 2008

Why it stopped: In view of the slowness of the inclusions and the difficulty of carrying out the study, it was decided to put an end to this study.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560118
Sponsor's protocol ID
CDR0000574147
Other IDs
RECF0287
Acronym
MGFOT1
Status last verified
Feb 2025
First submitted
16 Nov 2007
Last updated
14 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
No

Publications

  • Baughan CA, Hall VL, Leppard BJ, Perkins PJ. Follow-up in stage I cutaneous malignant melanoma: an audit. Clin Oncol (R Coll Radiol). 1993;5(3):174-80. doi: 10.1016/s0936-6555(05)80321-8.

    PubMed 8347541

  • Sirott MN, Bajorin DF, Wong GY, Tao Y, Chapman PB, Templeton MA, Houghton AN. Prognostic factors in patients with metastatic malignant melanoma. A multivariate analysis. Cancer. 1993 Nov 15;72(10):3091-8. doi: 10.1002/1097-0142(19931115)72:103.0.co;2-v.

    PubMed 8221576

  • Battayani Z, Grob JJ, Xerri L, Noe C, Zarour H, Houvaeneghel G, Delpero JR, Birmbaum D, Hassoun J, Bonerandi JJ. Polymerase chain reaction detection of circulating melanocytes as a prognostic marker in patients with melanoma. Arch Dermatol. 1995 Apr;131(4):443-7.

    PubMed 7726587

  • Hauschild A, Michaelsen J, Brenner W, Rudolph P, Glaser R, Henze E, Christophers E. Prognostic significance of serum S100B detection compared with routine blood parameters in advanced metastatic melanoma patients. Melanoma Res. 1999 Apr;9(2):155-61. doi: 10.1097/00008390-199904000-00008.

    PubMed 10380938

  • Kageshita T, Yoshii A, Kimura T, Kuriya N, Ono T, Tsujisaki M, Imai K, Ferrone S. Clinical relevance of ICAM-1 expression in primary lesions and serum of patients with malignant melanoma. Cancer Res. 1993 Oct 15;53(20):4927-32.

    PubMed 8104688

  • Luca M, Hunt B, Bucana CD, Johnson JP, Fidler IJ, Bar-Eli M. Direct correlation between MUC18 expression and metastatic potential of human melanoma cells. Melanoma Res. 1993 Feb;3(1):35-41. doi: 10.1097/00008390-199304000-00006.

    PubMed 8471835

  • Hieken TJ, Ronan SG, Farolan M, Shilkaitis AL, Das Gupta TK. Molecular prognostic markers in intermediate-thickness cutaneous malignant melanoma. Cancer. 1999 Jan 15;85(2):375-82. doi: 10.1002/(sici)1097-0142(19990115)85:23.0.co;2-1.

    PubMed 10023705

  • Smolle J, Hofmann-Wellenhof R, Kerl H. Prognostic significance of proliferation and motility in primary malignant melanoma of the skin. J Cutan Pathol. 1992 Apr;19(2):110-5. doi: 10.1111/j.1600-0560.1992.tb01351.x.

    PubMed 1597566

  • Middleton MR, Grob JJ, Aaronson N, Fierlbeck G, Tilgen W, Seiter S, Gore M, Aamdal S, Cebon J, Coates A, Dreno B, Henz M, Schadendorf D, Kapp A, Weiss J, Fraass U, Statkevich P, Muller M, Thatcher N. Randomized phase III study of temozolomide versus dacarbazine in the treatment of patients with advanced metastatic malignant melanoma. J Clin Oncol. 2000 Jan;18(1):158-66. doi: 10.1200/JCO.2000.18.1.158.

    PubMed 10623706

  • Avril MF, Bonneterre J, Delaunay M, Grosshans E, Fumoleua P, Israel L, Bugat R, Namer M, Cupissol D, Kerbrat P, et al. Combination chemotherapy of dacarbazine and fotemustine in disseminated malignant melanoma. Experience of the French Study Group. Cancer Chemother Pharmacol. 1990;27(2):81-4. doi: 10.1007/BF00689087.

    PubMed 2249337

  • Avril MF, Bonneterre J, Cupissol D, Grob JJ, Kalis B, Fumoleau P, Kerbrat P, Israel L, Fargeot P, Lambert D, et al. Fotemustine plus dacarbazine for malignant melanoma. Eur J Cancer. 1992;28A(11):1807-11. doi: 10.1016/0959-8049(92)90008-p.

    PubMed 1389514

  • Mechl Z, Krejci P. Cis-diamminedichloroplatinum in the treatment of disseminated malignant melanoma. Neoplasma. 1983;30(3):371-7.

    PubMed 6683360

  • Flaherty LE. Rationale for intergroup trial E-3695 comparing concurrent biochemotherapy with cisplatin, vinblastine, and DTIC alone in patients with metastatic melanoma. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S15-20.

    PubMed 10685653

  • Jacquillat C, Khayat D, Banzet P, Weil M, Fumoleau P, Avril MF, Namer M, Bonneterre J, Kerbrat P, Bonerandi JJ, et al. Final report of the French multicenter phase II study of the nitrosourea fotemustine in 153 evaluable patients with disseminated malignant melanoma including patients with cerebral metastases. Cancer. 1990 Nov 1;66(9):1873-8. doi: 10.1002/1097-0142(19901101)66:93.0.co;2-5.

    PubMed 2224783

  • Jacquillat C, Khayat D, Banzet P, Weil M, Avril MF, Fumoleau P, Namer M, Bonneterre J, Kerbrat P, Bonerandi JJ, et al. Chemotherapy by fotemustine in cerebral metastases of disseminated malignant melanoma. Cancer Chemother Pharmacol. 1990;25(4):263-6. doi: 10.1007/BF00684883.

    PubMed 2403853

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing fotemustine in people with Melanoma (Skin), run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.

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: stopped early, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: In view of the slowness of the inclusions and the difficulty of carrying out the study, it was decided to put an end to this study.). Results are not available in the source record.

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.

What does the primary outcome measure?

Relationship between MGMT expression and response to fotemustine (time frame: from date of inclusion to death of patient). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560118, which also lists 32 linked publications.

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 14 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in