Skin and Connective Tissue Diseases

All Conditions

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Keratosis

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Nevus

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Skin Diseases, Papulosquamous

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Dermatologic Agents

All Drugs and Chemicals

Acitretin

This is a continuing study which evaluates the long-term safety and efficacy of oral acitretin in an open manner in the treatment of psoriasis, cutaneous disorders of keratinization, multiple basal cell carcinomas and other retinoid responsive diseases.

The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases

National Cancer Institute (NCI)

Blood and Lymph Conditions

Immune System Diseases

Heart and Blood Diseases

Lymphoma

Lymphoma, T-Cell, Cutaneous

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma, T-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Cutaneous T-cell Lymphoma

Lenograstim

Adjuvants, Immunologic

Immunologic Factors

ATRA plus G-CSF (filgrastim, NEUPOGEN (R)) combination

Kirsten E Herbert, MBBS

Miles Prince, MBBS

Hematopoietic stem and progenitor cells (HSPC) are used for transplantation in patients undergoing high dose therapy for the treatment of a range of cancers.

* HSPC are collected from the bloodstream after treatment with medications that cause the HSPC to move from the bone marrow into the bloodstream, a process called mobilization
* between 5 and 60% of patients can fail to collect enough HSPC for a transplant, using current mobilization techniques
* this study aims to assess the safety of combining a derivative of vitamin A, ATRA with G-CSF (the drug most commonly used to mobilize HSPC)
* ATRA has never been combined with G-CSF for mobilization of HSPC and therefore a study is needed to assess the safety of this combination, and whether it successfully mobilizes HSPC

HSPC mobilization is normally achieved using cytokines such as G-CSF, or occasionally GM-CSF, often in combination with myelosuppressive chemotherapy.

Studies in the mouse model have shown that retinoids (vitamin A derivatives) can be combined with G-CSF, and that this combination synergizes to enhance HSPC mobilization over that seen with G-CSF alone.

This trial aims to assess the safety and mobilization efficacy of combining mobilizing doses of G-CSF with a standard dose of ATRA, using a treatment regimen derived from the earlier murine studies.

In this phase I pilot study, six patients with multiple myeloma or cutaneous lymphoma will be treated with ATRA plus G-CSF, and safety and toxicity data collected for the two week study drug period plus a further two weeks' follow-up. The primary endpoint is safety and toxicity, the secondary endpoint is an observation of the mobilization efficacy as demonstrated by CD34+ cell counts over the study period. Patients will not undergo stem cell collection during this study, as this is purely an observational study. Participating patients will not be those who would normally be scheduled for stem cell collection and transplantation in the near future, but rather patients with stable disease who are not candidates for imminent transplantation, or who have collected adequate HSPC on previous mobilization attempts and are currently being observed.

Cutaneous lymphoma and multiple myeloma are chosen as suitable disease states for this study as there is in vitro evidence of a possible disease benefit of retinoids in these disorders. If disease response is noted during the study or follow up period, ongoing ATRA will be offered at the discretion of the treating physician.

ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells

A Phase I Study of Haematopoietic Stem Cell Mobilization Using G-CSF With ATRA in Patients With Cutaneous Lymphoma and Multiple Myeloma

The Leukemia and Lymphoma Society

Peter MacCallum Cancer Centre, Australia

Breast Neoplasms

Breast Diseases

Bone Density Conservation Agents

Antineoplastic Agents

Tamoxifen

Isotretinoin

Tretinoin

Alitretinoin

Keratolytic Agents

9-cis-Retinoic Acid

This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.

This is a Phase I study of the combination tamoxifen and 9-cis-Retinoic acid in patients with breast cancer. The primary objective of the study is; 1) to determine the maximum tolerated dose of 9-cis-Retinoic acid in combination with Tamoxifen and to determine the overall and dose limiting toxicities. Other objectives are: 2) to determine the effect of Tamoxifen on the pharmacokinetics of 9-cis-Retinoic acid; 3) to evaluate the anti-tumor activity of this combination therapy within the context of a phase I study; 4) and to determine the expression of surrogate biomarkers of breast carcinogenesis before and after treatment.

A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Evaluation of Oral Acitretin in the Treatment of Psoriasis, Cutaneous Disorders of Keratinization, Multiple Basal Cell Carcinomas and Other Retinoid Responsive Diseases	NCT00005660	Basal Cell Carc... Keratosis Palma... Psoriasis		-	National Institutes of Health Clinical Center (CC)
ATRA Plus G-CSF for Mobilization of Hematopoietic Stem and Progenitor Cells	NCT00400556	Multiple Myelom... Cutaneous Lymph...	ATRA plus G-CSF...	18 Years - 70 Years	Peter MacCallum Cancer Centre, Australia
A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients	NCT00001504	Breast Cancer Breast Neoplasm	9-cis-Retinoic ...	-	National Institutes of Health Clinical Center (CC)

Spots Global Cancer Trial Database for retinoids

Every month we try and update this database with for retinoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for retinoids

Every month we try and update this database with for retinoids cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for retinoids cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.