Evaluation of the Biological Safety and Clinical Efficacy of 177 Lu-EDTMP for Bone Pain Palliation in Metastatic Prostate Cancer (PhaseI/II Clinical Trial)

Closed for proposals

Project Type

Coordinated Research Project

Project Code

E13033

CRP

1412

Approved Date

8 December 2006

Status

Closed

Start Date

15 March 2007

Expected End Date

31 March 2012

Completed Date

4 April 2012

Description

Prostate cancer is currently one of the most common malignancies worldwide. About 50-70% of patients present with locally advanced stage and about 15-30% have bone metastases at the time of diagnosis. In advanced stage of the disease, cancer spread to the skeleton occurs in a majority of patients, with skeletal metastases being predominantly osteoblastic in nature. Disseminated skeletal involvement results in hypercalcemia, anaemia, factures and spinal cord compression as well as intractable pain, complications that may profoundly impair quality of life. Radionuclide Therapy is an alternative modality to "Hemibody" Radiation Therapy in this particular group of patients. Treatment with bone seeking beta-emitting radiopharmaceuticals has been shown to reduce pain for a prolonged period and to improve quality of life with no serious side effects. 177Lu-EDTMP has a very good potential for use in in-vivo therapy, because of its f'avourable decay characteristics. Effective cancer management requires standardizing and coordinating treatment protocols and by making available economically affordable therapies. Our approach will utilize available capacities in Member States. This CRP will generate know- how and expertise in participating Medical Institutions to explore the potential therapeutic efficacy of this promising bone pain palliating agent. The overall objective of this CRP aims at evaluating the biological safety and clinical efficacy of 177Lu-EDTMP for bone pain palliation in metastatie prostate cancer in a Phase I and Phase II clinical trial.

Objectives

1.Demonstrate the feasibility, biological safety and clinical efficacy of the 177Lu-EDTMP to relief bone pain in patients with disseminated metastatic prostate cancer not responsive to hormone therapy.
2. To improve access to cost effective treatment by developing appropriate infrastructure, radio pharmacy and clinical institutions to promote effective use of targeted radionuclide therapy in developing member states.

Specific objectives

Asses the maximum tolerated dose and toxicity profile and assess the clinical effectiveness in palliating bone pain in a randomized trial by comparing two levels of injected activities of Lu-177 to patients with breast cancer or prostate cancer.

Assess the efficacy and safety of 177Lu-EDTMP for bone pain palliation in patients with breast cancer and hormone refractory prostate cancer with bone metastases.

Impact

Improve cancer patients' management.
Enhance knowledge of professionals involved (Physicians, medical physicists technologists) in conducting internal dosimetry and performing cancer therapy using unsealed radioisotopes.
Create and enhance capacities to achieve self reliance with respect to the production and delivery of therapeutic radiopharmaceuticals

Relevance

The CRP is highly relevance as it tackles the need to provide a palliative care to cancer patients,
It in addition enhanced professionals' knowledge and created capacities to conduct more advanced targeted molecular therapies using tumour-targeting peptides (e.g. somatostatin receptors analogues) for the treatment of cancers expressing SSA.

CRP Publications

Type

Abstract

Year

2011

Publication URL

http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/52/1_MeetingAbstra…

Country/Organization

3. Saeed S, Zaknun J, Jameel G, Irfan J, Fatima S, Qureshy A, Afzal M, Qureshi F, Mariani G. 177Lu-EDTMP - A bone pain palliating agent: Biodistribution and skeletal uptake in osseous metastatic patients. J. Nucl. Med. MEETING ABSTRACTS 52: 1750.

Type

original paper

Year

2015

Publication URL

https://link.springer.com/article/10.1007/s00259-014-2862-z

Description

The purpose of this study was to evaluate the efficacy and safety of 177Lu-EDTMP for pain palliation in patients with bone metastases from castration-resistant prostate and breast cancer. The secondary objective was to compare low-dose and high-dose 177Lu-EDTMP in bone pain palliation

Country/Organization

Agarwal, K.K., Singla, S., Arora, G. and Bal, C., 2015. 177 Lu-EDTMP for palliation of pain from bone metastases in patients with prostate and breast cancer: a phase II study. European journal of nuclear medicine and molecular imaging, 42(1), pp.79-88.

Type

Abstract

Year

2011

Publication URL

http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/52/1_MeetingAbstra…

Country/Organization

1.Zaknun J, Bal CS, Dupont P. Pharmacokinetics and dosimetry of the bone-seeking agent 177Lu-EDTMP in patients with metastatic prostate cancer. J. Nucl. Med. MEETING ABSTRACTS 52: 1748.

Type

Abstract

Year

2011

Publication URL

http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/52/1_MeetingAbstra…

Country/Organization

5. Zaknun J, Bal CS, Saeed S, Jameel G, Gaudiano J, Qureshy A, Traino C, Mariani G. Clinical feasibility of Lu-177 EDTMP prescribed bone marrow irradiation dose concept in bone pain palliation. J. Nucl. Med. MEETING ABSTRACTS 52: 1753.

Type

Abstract

Year

2011

Publication URL

http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/52/1_MeetingAbstra…

Country/Organization

4.Liu X, Liu C, Li H, Xiang X, Luo Z, Wang Y, Zaknun J. 177Lu-EDTMP for bone pain palliation in metastatic prostate and breast cancer: A phase II trial. J. Nucl. Med. MEETING ABSTRACTS 52: 1752.

Type

original paper

Year

2013

Publication URL

https://journals.lww.com/nuclearmed/Abstract/2013/02000/Efficacy_and_Safety_of_1…

Description

Purpose 177Lu-labeled ethylenediamine-N,N,N',N'-tetrakis methylene phosphonic acid (177Lu-EDTMP), was used to palliate metastatic bone pain as a new bone-seeking radiopharmaceutical. In this phase II study, we assessed the efficacy and safety of 177Lu-EDTMP for bone pain palliation in patients with breast cancer and hormone refractory prostate cancer with bone metastases.

Country/Organization

Yuan, J., Liu, C., Liu, X., Wang, Y., Kuai, D., Zhang, G. and Zaknun, J.J., 2013. Efficacy and safety of 177Lu-EDTMP in bone metastatic pain palliation in breast cancer and hormone refractory prostate cancer: a phase II study. Clinical nuclear medicine, 38(2), pp.88-92.

Type

original paper

Year

2012

Publication URL

http://www.ncbi.nlm.nih.gov/pubmed/22001721

Country/Organization

Liu C, Brašic JR, Liu X, Li H, Xiang X, Luo Z, Wang Y, Kuai D, Zhang G, ZaknunJJ. Timing and optimized acquisition parameters for the whole-body imaging of 177Lu-EDTMP toward performing bone pain palliation treatment. Nucl Med Commun. 2012;33:90-96.

Type

Original paper

Year

2011

Publication URL

http://jnumedmtg.snmjournals.org/cgi/content/meeting_abstract/52/1_MeetingAbstra…

Country/Organization

2.Liu C, Liu X, Wang Y, Li H, Luo Z, Zaknun J. Study on the skeletal retention and bone marrow dose of Lu-177-EDTMP in patients with bone metastasis. J. Nucl. Med. MEETING ABSTRACTS 52: 1749. Commun. 2012;33:90-96.

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