Update on the ARQ 197 Clinical Trial (November 23):
The new clinical trial (read below) is now open and at least two ASPS patients are already participating in it.
If you are interested to join the trial please read the information below and contact Dr. Isett Laux, the study coordinator for this study.

Tel: 310-633 8400, 310-633 8419
From the site of “Premiere Oncology”:

“A Phase 2 Study of ARQ 197 in Patients with Microphthalmia Transciption Factor Assciated Tumors.

The purpose of this study is to determine the overall response rate in patients with unresectable locally advanced or metastatic alveolar soft parts sarcoma, clear cell sarcoma or translocation associated renal cell carcinoma. Since this study will allow patients over 13 years of age, it will also be evaluating the safety of ARQ 197 in adolescent and young adult patients with MiT tumors. Patients will be followed for the effect of the drug in terms of side effects, how it affects their disease, and pharmacokinetic testing. Pharmacokinetics (PKs) is a method to determine the levels of a drug in the blood and see how the body absorbs, distributes, metabolizes and eliminates it. This is done by frequent blood draws on key days during the first 4 weeks of treatment.

ARQ 197 is an oral drug in the family of targeted therapies. It is a c-Met inhibitor and is not approved by the FDA. In this study, it is an investigational drug.”

For direct link to “Premiere Oncology” website please click here.

______________________________________________________

Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com

Dear ASPS community. As you probably know, the GVAX cancer vaccine clinical trial has been open since January 2006 and is still recruiting new patients. In addition to Alveolar Soft Part Sarcoma, it also recruits Clear Cell Sarcoma, Renal Cell Carcinoma and Melanoma patients.

I would like to share with you an e-mail from a parent whose child, a clear cell sarcoma patient participated in the GVAX clinical trial. I hope that this e-mail will encourage other patients on that trial to tell us about their own experience in this trial. For comments and further discussion please click on: Forum, Dana Farber Cancer Vaccine Clinical Trial (GVAX).

“I have been a reader of the iCureASPS website since its inception. Thank you so much for the hard work and efforts. My child was diagnosed five years ago with Clear Cell Sarcoma (CCS) and he was selected to participate in the GVAX cancer vaccine trial at the Dana Farber in Boston.

He was diagnosed in 2002. His primary tumor of 3.5 cm was located in the left upper thigh. At that time signs of tumor spread were not evident except for one 2mm lung nodule that could be scar tissue from past unrelated sickness. Surgery to remove the primary tumor was the only treatment option which was recommended for him.

BUT – in February of 2006, the cancer was found growing in two lymph nodes. In addition to the 2mm lung nodule that remained unchanged, three new nodules were found as well. Their dimensions were of 6mm, 4mm and 3mm. My child never had radiation or chemotherapy. The doctors thought that he was an “ideal” candidate for the GVAX cancer vaccine clinical trial because his immune system was intact. The doctors used the two affected lymph nodes for the preparation of the cancer vaccine.

I am very glad to report that today after 13 GVAX injections since February 2006 the 4mm lung tumor disappeared. The 3mm tumor remains unchanged and no new tumors have been discovered. The 6mm lung nodule was removed in August 2006, six months into the clinical trial. Analysis of that tumor showed T-cell infiltration, which may indicate an enhanced immune response against the tumor.

The GVAX injections caused no side effects except for redness around the injection site that would last for about a week after each injection followed by some itching. The next scans for my child will be taken in November 07. Thank you so much for the hard work you’ve done. I would like also to say that I find the doctors at Dana Farber wonderful people.”

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Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com

A collaboration between scientists from The Memorial Sloan-Kettering Cancer Center in New York, Dana-Farber Cancer Institute in Boston and The Johns Hopkins Hospital in Baltimore reveals a new therapeutic target in Alveolar Soft Part Sarcoma.

The results of that collaboration were recently published in the scientific Journal Cancer Research volume 67 pages 919-929, 2007.

The new study demonstrates that ASPL-TFE3 (the specific fusion protein of ASPS) upregulates the expression of the active form of the MET gene product. MET activation leads to increased cell proliferation, survival, motility, and to the degradation of extracellular matrix. All of those MET-dependent activities contribute to tumor growth, invasiveness, and metastasis.

The new study from the laboratories of Marc Ladanyi, David Fisher and Ian Davis demonstrates that the elimination of MET or its inactivation by a new drug, PHA665752, inhibit cancer cell proliferation, adhesion, motility, and invasion. These important findings show a role for MET in human cancers that contain the specific TFE3 fusion protein. “MET inhibitors” are therefore a new hope for a line of therapies that may cure ASPS.

Here is a partial list of a few “MET inhibitors” that are currently in different phases of clinical development:

1. XL880
2. AMG 102
3. SGX523
4. SU11274
5. PHA6657524
6. AV299

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Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com

1. Phase II Study of Sorafenib in Patients With Advanced Soft Tissue Sarcomas

2. Sorafenib in Treating Patients With Soft Tissue Sarcomas

Alveolar Soft Part Sarcoma (ASPS) is highly angiogenic: it involves intensive growth of new blood vessels into the tumor. Those blood vessels connect the tumor to the blood system, supply oxygen and nutrients to the tumor, remove waste and enable dissemination of tumor cells into the body through this connection to the blood stream. Therefore, it is possible that the application of specific drugs, which may inhibit the creation of new blood vessels, is a way to combat ASPS.

Sorafenib (Nexavar) is designed to interfere with growth of new blood vessels and the growth of new cancer cells.

If you wish to participate in any of the Sorafenib (Nexavar) clinical trials, talk to your doctor and/or contact one of the medical centers across the USA, that are listed in the links above, to determine if those clinical trials are right for you.

__________________________

Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: mailto:landesmany@yahoo.com

October 11, 2006

The clinical trial “GVAX Cancer Vaccine” started in January 2006 and enrollment is still open to new patients. So far 11 patients were selected to participate in the trial. Eight of those patients have the diagnosis of Alveolar Soft Part Sarcoma (ASPS). All the eight ASPS patients have completed the study. There have been no serious toxicities associated with the GVAX cancer vaccine and it has been tolerated extremely well.

Encouraging evidence of biological activity was observed in skin biopsies from sites that were injected with killed tumor samples, after patients had received the vaccine. In one case, biological activity was noted in a tumor that was resected from a patient at the end of the vaccination period.

Patients who participated in the Cancer Vaccine GVAX trial have now the option to join, within 4 months following the end of their last injection, to an additional clinical trial that uses injections of gamma interferon and GMCSF. Co-injections of gamma interferon and GMCSF aim to maintain and /or increase the body’s immune response to alveolar soft part sarcoma cancer cells.

It is too early in the study to make any clinical interpretations and some laboratory studies are still on - going as well.
__________________________

Yosef Landesman, Ph.D.
President & Cancer Research Director
Cure Alveolar Soft Part Sarcoma International (iCureASPS)
e-mail: landesmany@yahoo.com